Keywords

1 Introduction

We began in Chap. 1 by asking two questions. 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? and What governance challenges and opportunities will shape the future applications of gene editing in the agrifood system? Throughout this book, we have explored various elements of gene editing in the agrifood system—the technology and its applications, the regulatory system, the intellectual property landscape, as well as innovations and emergent applications and platforms in the genome editing space. We have discussed the governance challenges facing regulators responsible for evaluating yet unknown, emergent innovations. It has been the goal of this book to provide the reader with ideas and insights into why gene editing in agriculture has not advanced as quickly as initially expected.

The heterogenous global regulatory landscape for gene edited plants, the various techniques that can be used to achieve gene edits, the complicated patent and licensing landscape, as well as the lack of consensus of what constitutes a ‘living modified organism’ and how gene edited agrifoods should be tracked and could be labelled are all factors contributing to the current precarious status of gene editing in the agrifood system. The future governance of gene editing in agrifood depends on how individual countries or trade blocs decide to proceed with regulatory definitions of gene edited agrifoods. It also depends on what emergent techniques are in the pipeline, and the extent to which they relate to current gene editing techniques like CRISPR or take another route to editing the genome with MAD7 or RNAi technology, for example.

2 Regulatory Systems in Flux

Many opportunities and uncertainties surround the future of gene editing. As we discussed in Chaps. 2 and 4, new nucleases with capabilities for gene editing are being discovered every year. What does this mean for the future of new breeding techniques in agrifood? There will be more options for researchers and developers to unlock beneficial traits in the genome of agrifood plants, and though not a focus of this book, also livestock. Gene editing applications for fungi and microbes are also emerging as important components of a sustainable, climate smart agrifood system. These are important advancements that have benefits, not only for producers, but also consumers and, more broadly, the planet. If we can harness gene editing to improve upon ways to make agriculture more sustainable and edit plants so that they are more adaptable to turbulent climactic changes, the abilities for smallholder farmers to be more productive on the land with fewer pesticides and/or fertilizers can provide a more regionally stable food source.

The major challenges lie in getting these technologies into the market, and to the people who can benefit from them the most, without being financially prohibitive. This is where harmonization of regulatory frameworks, even on a regional basis, as is the case in Latin America, South America and potentially in sub-Saharan Africa will be key. The complexity of the patent and licensing landscape further deters progress in the area of proliferation. At this point, there does not appear to be any consensus among patent and/license holders on how to proceed.

Europe could be a game changer if the European Union decides to regulate gene edited agrifoods differently than GMOs. The uncertainty surrounding the EU remains a major limitation to the applicability of CRISPR-Cas systems in Europe’s agricultural sectors (Cardi et al., 2023: 18). But we have yet to see whether the recent EU proposal moves forward at the member-state level or is rejected. As discussed in Sect. 5.3, there are varying expert opinions on which direction the EU will go. Rejecting the new breeding techniques proposal may disadvantage the EU in terms of global competitiveness in agricultural products and the ability to address agricultural sustainability and climate change. The eventual direction the EU chooses will have implications for its trading partners, especially those in African countries like Uganda, Kenya and Tanzania that are in the process of finalizing their regulatory frameworks for gene edited agrifoods. Informant 19 (a private sector representative) said of smallholders in sub-Saharan Africa,

…much of the activism against modern technologies is really out of touch with what farmers are facing. Farmers are not looking for GMOs. Farmers are not looking for gene edited technologies. Farmers are like, ‘I’m grappling with this pest. Do you know any solution that can help?’ I wish there was a model that would just allow farmers to have the opportunity to choose.

Canada, Argentina, and Japan appear to be regional leaders in the gene editing regulatory area, all using the case-by-case approach to the risk assessment of novel gene edited agrifoods while, in the Canadian case, embracing the deliberative governance approach. These models, and the principles they embody, may be what regulators in other jurisdictions look towards as they finalize their own regulatory frameworks for gene edited plants. The countries that have taken the ‘product-based approach’ may gain stronger agricultural trade ties with countries taking similar regulatory approaches. We have yet to see if taking this approach yields more commercialized gene edited agrifoods that have useful traits in these jurisdictions and beyond.

It is also unclear which direction China will go with its regulatory framework, and how that will or will not align with the patent and licensing situation in the country. Informant 12 (an academic researcher/social scientist) provided interesting insights into China’s role in the race for dominance in the gene editing space, commenting that there is:

…a lot of discussion in the international space that China has been intentionally obfuscating their intentions on moving forward as they get some mastery in this space…they’re a market leader as they enter the space and have internal developer expertise. So as they enter that space, they’re not just opening themselves up to a bunch of foreign entities entering the Chinese market. They’re able to have a lot of expertise to service their own market and to be exporters…It’s very, very paralyzing for the international regulatory community trying to anticipate what China is going to do.

We have yet to see what China’s role will be in the global gene editing landscape, if and when licenses are issued for the CRISPR techniques patented by state-run institutions. It may turn out that the patented techniques are useful in certain contexts and not others. China may also become more influential in global standards setting for new breeding techniques and IP discussions compared to the EU if the 2023 proposal to revise regulations covering gene editing in the EU agrifood system are thwarted. The rest of the world is looking to these countries to see which direction they will take gene editing in agriculture.

3 Navigating the Patent Landscape

As discussed in Sect. 5.4, the patent landscape is complicated, and the dynamics of the sector are evolving rapidly. In terms of the patent and licensing landscape, harmonization that can simplify the environment for researchers is needed. Those experimenting with gene editing techniques need a degree of certainty about what IP legalities are relevant to their discoveries, which are not, and which might be in the future. The fact that successfully filed patents are publicized 18 months after they are approved is problematic for researchers and developers in this area, who may be violating a patent in the meantime without knowing it. There are calls to democratize the licensing landscape so that researchers in less developed countries can develop agrifood products that may benefit small-scale farmers, sustainability, and food security efforts within their own countries without paying hefty licensing fees and royalties.

There are also worries that the complicated IP issues surrounding CRISPR-Cas systems and other gene editing technologies will concentrate IP and research among only the largest multinational companies that can afford a team of legal experts in patent law, licenses, and royalty pay-outs. The Broad Institute’s joint licensing agreement with Corteva is a step forward, but it is ad hoc and only relevant to the patents and licenses that these entities hold. Some argue that the revolutionary CRISPR technique should be liberalized and be freely available for use to advance science in agrifood research globally, without the financial limitations of patents, licensing, and royalty payments, especially for those seeking solutions to social goods such as addressing global food insecurity, climate change and sustainability in the developing world. Informant 18 (a research scientist with an NGO) sees this as a pressing matter, especially in the wake of the global supply chain disruptions during and after the COVID-19 global pandemic. They state:

on global trade and the importance of developing crops for the developing world, I think when you have the supply chains being disrupted, people would like to look for supply chains that are more secure in terms of food. So, if your commodities were coming basically from one part of the world and the supply chains are completely disrupted, trade wars being one such example, you would look for policies which ensure that the production and productivity of commodities in those specific zones is not stopped. So gene editing will play a role.

Informant 8 (a private sector representative) was concerned about freedom to operate complications arising from the current state of IP in gene editing, and was also concerned by objections to gene editing in the agrifood system saying,

I hope we get to a point where we can collectively recognize that the market is big enough for everyone, and choice is important, and we can make this work without either killing the organic sector or killing the rest of the sector by making technology so difficult to use that it’s not possible.

One issue that remains unclear at this stage in the development of gene edited agrifoods is whether or not gene editing a registered variety of a plant will be legally recognized as the same variety. Is gene editing a particular variety of plant legally equivalent to the already registered variety, or is a gene edited variety legally different? This is an ongoing issue that is not an easy fix. It will take time, and employing aspects of deliberative governance, to get a clearer picture of how the legalities of commercializing gene edited agrifoods will evolve in the future.

4 Consumer Considerations

Though not a central focus of this book, it is worth commenting on consumer preferences and their role in the future of gene edited agrifoods. Consumer preferences appear to be much more significant in the development and efforts to commercialize gene edited agrifoods featuring consumer-oriented traits, compared with the development of GMOs which are argued to benefit producers (and IP rights holders) more so than consumers (Yang & Hobbs, 2020a). For some developers, there is less resistance to labelling gene edited products compared with the labelling issues that affect GMOs, because they have found that consumers are not as resistant to gene edited agrifoods as they are to genetically modified foods (using SDN3/transgenes) (Yang & Hobbs, 2020a, b). And in fact, some companies want labels on their food products indicating that they are products of gene editing. As Informant 9—a representative of a private company expressed to us in an interview (while displaying a prototype label of a gene edited food product ready for commercialization):

…in terms of acceptance, acceptance will happen when we make products that consumers and people experience. I wanna show the back of the package…this is how we’re talking about gene editing. So, you’ve got this better flavor by CRISPR. And then a QR code…there’s been a real positive reaction.

In Kolondinsky and Lusk’s (2018) study of labelling gene edited agrifoods, they claim that having simple labels on consumer products reduces opposition to the technology. The FAO’s recent document on gene editing in the agrifood system states,

…labelling rules should be framed in a harmonized global system based on transparent science-based consideration of risks, in which new traits in food would be included in a label if they represented a fundamental change in the composition of the food; production method would not be a mandatory labelling requirement (FAO, 2022: 24).

Labelling may act as a deterrent, and consumers may avoid products carrying a gene edited label. But as Informant 12 (an academic researcher) notes, gene editing in the food system may not be top of mind for most people, despite what researchers may think:

I think the public has a very complicated relationship with food in lots of different attributes, and that potentially a plurality of consumers may not care either way, it’s just not relevant to their lives…You can just choose not to eat this in theory, right? If it’s labelled, you can choose not to eat this. If you’re taking away people’s ability to choose what they eat it gets more complicated… I think the public cares about this, but not nearly as much as regulators think they do.

Informant 9, who works in the private sector shared with us their experiences with consumer acceptance of gene edited agrifoods:

…acceptance will happen when we make products that consumers and people experience…It’s not driven by ‘let me help you understand what this is and how we tap into natural’. And it’s not GMO… this is how we’re talking about gene editing… so you’ve got this better flavor by CRISPR…[what matters is] does it look good? What’s in it? Color? Does it pop fresh, nutritious taste, right price? That’s it.

The gene edited agrifoods that have already received approval, such as the GABA tomato in Japan and the Pairwise leafy greens in the US, have nutritional, agronomic and/or environmental benefits that traditional breeding methods would require decades to achieve. Informant 19 (a scientist with an NGO) noted that consumer preferences are important reasons why developing countries should embrace the possibilities of gene editing in the agrifood sector. They noted:

…how crops are chosen is also because of the consumer preferences. So I would say, much of the research I know was happening when I was in Uganda was also related to when consumers complained about conventional beans taking too long to be cooked…We need beans that can be cooked very fast without spending so much money on firewood. Consumer preferences should determine which kind of crops and which kind of traits.

Prioritizing consumer demands for agrifoods like beans with thinner skins so they cook faster could revolutionize the lives of millions and help reduce deforestation by requiring less cooking fuel. Informant 9 explained that:

a more efficient utilization of the land helps to preserve diversity because you keep your footprint the same or less. If you’re finding alternatives to having to use more broadly applied pesticides that have other effects because you’ve made the plant itself, you’ve tapped into that sort of natural, variability that it has to resist disease. Then maybe you help that way, too. The regulatory system should be set up to incentivize that.

5 Climate Change and Sustainability

The development of agrifood traits using gene editing technologies could include the needs of smallholder farmers to better meet UN sustainability goals which include addressing climate change. There is active research around the potential for gene editing to assist in achieving goals related to climate change, sustainability, and biodiversity. As Informant 7 pointed out:

one of the things that we’re working on in my group is to use gene editing to reduce methane emissions from cattle just by increasing oil production in forage crops. So little things like that have this downstream consequence that could be really very beneficial.

They continue,

…trying to reduce methane emissions, increasing carbon capture potentially, there are all sorts of things to be done to try and make agriculture better for the environment and reduce the impact. I would say in terms of climate change and then, obviously a lot of people are doing work in terms of trying to improve adaptability of crops to climate change as well.

As to what stakeholders can do to move the needle forward in terms of acceptance of gene editing, Informant 1 (an academic researcher) stated,

…I think we need to do more research to better understand from both the public and private sector what barriers are…preventing you from making an additional investments, and until we know those answers I think it’s really tough to direct policymakers or anyone saying, ‘Here’s the policy changes that will increase our agriculture investments’ because I don’t think we fully comprehend what the public and private, and even the producer funding organizations, see as barriers to increase investment. And until we understand that I don’t think we’ll see much change in the dollars.

Using deliberative elements of governance, such as foresighting and scenario building, regulators are better able to address what relevant stakeholders perceive as barriers. Regulators can then see barriers from various viewpoints to determine where policy change can move the needle to maintain social license while fostering innovation, economic growth and making agriculture more sustainable through the use of new breeding techniques.

Informant 19 gave us a perspective from policymakers in sub-Saharan African countries that are developing regulatory frameworks for gene edited agrifoods. They urge scientists to take more consideration of the politics surrounding New Breeding Techniques in agriculture. They state,

I wish [scientists] understood the web of the policymaking process and how regulatory frameworks are designed. Being a scientist, you tend to always see the world through the lens of ‘everything should be based on science’ and we know that it is not only about science. So that’s one of the challenges. Also, scientists should take accountability. They tend to be so much absorbed in the science, forgetting that science does not thrive in just a vacuum. There is the social and political context in which these innovations will thrive in, and I wish scientists would think about the complexity around developing innovations that would thrive in the social political context in which it is designed.

6 Conclusions: Future Opportunities

Moving forward, what does the future look like for the governance of gene editing in the agrifood system? The goal of this book is to give readers a timely assessment of the technologies used to achieve gene edits in agrifood plants, and how regulatory systems are responding to these technologies. We have argued that the deliberative governance model is an approach that accommodates future yet unknown uncertainties, while maintaining rigorous health and safety protocols, risk assessments to protect human, animal, and environmental health, while acquiring social license. The Canadian case described in Chap. 3 (Sect. 3.4) highlights how elements of deliberative governance have been used to modify the regulatory environment for gene edited agrifoods. But there is much more to do. Better communication and attempts to understand the science are paramount for regulators, but it is also important for scientists to have some sense of how politics conditions what they do and what is possible for gene editing in the agrifood system.

In this book we have examined the complexity of fostering innovation in agriculture while governing the agrifood system. Various countries have chosen different regulatory paths, often a different balance between innovation, risk, health and safety, and where gene editing fits into climate change strategies, sustainable agriculture, and food security. As Informant 19 said when referencing discussions about GMOs in sub-Saharan Africa, part of gaining acceptance is that:

…people do not oppose newer technologies or controversial technologies because they don’t know it, but because of the assumptions that experts make. They think people are opposed because they don’t know GMOs, so let’s throw down all facts about GMOs and they will change their mind…It’s very important [to] not make assumptions as experts…frame the engagement in a way that speaks to what ordinary people value.

We can learn lessons from previous experiences with biotechnologies like GMOs in how to better communicate benefits in a transparent, engaging, and compassionate manner. When trying to identify barriers and obstacles, it is important to ask, ‘what do ordinary people value’?

In terms of steps forward, this book only scratches the surface of the economic, social, and policy issues that are part of the governance of gene edited agrifoods. More social science research is needed to identify the barriers and opportunities facing stakeholders flowing from the patent and licensing landscape. Ongoing, open dialogue needs to be facilitated by organizations directly involved in the science, policymaking and commercialization of gene edited agrifoods such as plant breeders, regulators, the private and public sector scientists, NGOs as well as community members. Future research could provide a better understanding of the environmental and nutritional potential of gene edited organisms like microbes and algae and how governance structures will address these applications. As the application of RNAi technology advances, policy makers need to figure out whether this technology will be regulated similarly to GMOs or gene edited agrifoods. Finally, there is a need for researchers to take a closer look at the role of Artificial Intelligence in synthetic biology and precision agriculture as they relate to gene editing platforms.

Many informants with whom we spoke were optimistic about the future of gene editing in the agrifood system. Informant 20, who works for an international NGO, said in regard to the future of gene editing,

genome editing products have the potential to bring some pretty excellent traits to the food system and I think once you get these products out there and people are familiar with them and the concept of manipulating genes, whether you’re putting a transgene in or you’re just changing and tweaking the base, they will become less scary in general to the public and to some politicians that may not be well versed in the science.

Despite the challenges in navigating the complex and evolving regulatory landscape for gene-editing applications in agriculture, this sense of optimism drives scientific discovery. Widespread recognition of the need to address these regulatory barriers offers further cause for optimism.