How Are Gene Editing Technologies Regulated in the Agrifood System?

Abstract

This chapter examines current governance and regulatory frameworks for gene edited agrifoods. We outline the role of international organizations, particularly the OECD, in facilitating the development of national-level policies toward gene editing. We detail the risk assessment regimes of countries with regulatory frameworks for biotechnologies, providing a summary of the current state of gene editing regulations in these countries. Our analysis places national-level regulatory frameworks into five categories: light regulation, strongly regulated and prohibited, proposed regulation, modified process, and no regulation. We describe how governing gene edited agrifoods requires balancing innovation with considerations of risk and benefits to the economy, society, and the environment. Finally, we discuss the Canadian case in greater detail to illustrate how deliberative governance has been employed in the regulation of gene edited agricultural plants.

In the end, every regulatory system is precautionary, because you don’t give automatic approvals.—Informant 6 (NGO representative)

1 Introduction

The central question that guides this book is why has gene editing—and specifically with the advent of the CRISPR-Cas9 system—not become the big breakthrough in agricultural biotechnology it was touted as when discovered in 2012? Despite its less-than-ideal introduction into the world, CRISPR-Cas9 has made many inroads in agricultural research and the development of marketable agrifoods. However, there is currently no international consensus on how gene edited organisms and products should be regulated. Countries have the autonomy to determine if gene edited agrifoods fall under the regulatory framework of the Cartegena Protocol on Biodiversity (CPB) and the Convention on Biological Diversity (CBD) and whether or not they are included in the definition of a Living Modified Organism (LMO).

In this chapter, we examine the role of regulation in the management and use of gene editing in the agrifood system. Many regulatory typologies have developed over the years, placing countries into specific groups based on their adherence to the Cartagena Protocol and its definition of GMOs and LMOs. Documentation of the evolution of regulations covering gene editing are widely available and referenced here (some examples include Laaninen, 2020; Shukla-Jones et al., 2018; NASEM, 2017; Ahmad et al., 2021; FAO, 2022a, b; Vora et al., 2023). Generally speaking, regulatory systems fall into five categories: light, strong/prohibited, proposed, modified and no regulation. The embeddedness of the Cartagena Protocol in regulatory frameworks largely determines where gene editing falls in terms of its allowable uses in the agrifood sector (research & development, environmental release, commercialization).

This chapter synthesizes the general issues which countries that currently regulate gene editing are addressing, rather than providing detailed analyses of the responsibility and approach of each national regulatory agency, which is beyond the scope of the chapter. Details regarding the technical responsibilities of national regulatory agencies for regulating gene edited agrifoods can be found in various well-researched publications and websites such as the Genetic Literacy Project’s ‘Global Gene Editing Regulation Tracker’ and are not repeated here (see Entine et al., 2021; Ahmad et al., 2021; Vora et al., 2023).¹ Instead, this chapter provides a snapshot of the current country-specific approaches to regulating gene edited crops and agrifoods to provide a better understanding of how regulatory frameworks may evaluate the biosafety of new plant breeding techniques on the horizon. Since many countries use their biosafety protocols for biotechnology as the foundation for regulating gene editing, this chapter assesses the state of regulation for agricultural biotechnology as it pertains to gene editing.

Over the last decade, there have been ongoing international discussions seeking legal clarity pertaining to the status of genome editing and derived products. Key regions around the globe have adopted different positions (Lassoued et al., 2021). Harmonized regulatory blocs have emerged in South America, Central America, Africa, North America, and Europe, though within regions there are multiple approaches to regulating gene edited agrifoods (see Sect. 3.3). These are functional agreements that allow for countries in the same geographic region to harmonize aspects of their regulatory frameworks to facilitate trade. We begin by discussing the current state of regulatory frameworks, then how each regulatory regime assesses environmental, human and animal health, and biosafety risks.

2 International Organizations and the Regulation of Gene Edited Organisms

The Organisation for Economic Co-operation and Development (OECD) Conference on ‘Genome Editing: Applications in Agriculture – Implications for Health, Environment and Regulation’ took place in Paris in 2018. It explored the “safety and regulatory considerations raised by genome edited products, with the aim to favour a coherent policy approach to facilitate innovation involving genome editing and will bring together policy makers, academia, innovators and other stakeholders involved in the topic.”² It brought together relevant stakeholders (scientific experts, regulators, company representatives, etc.) from over 35 countries (OECD, 2018; Friedrichs et al., 2019). Participants in the Conference expressed the importance of fashioning regulatory approaches for genome editing to achieve policy objectives that consider precaution and innovation through better communication (Menz et al., 2020: 13). Though some of the countries discussed here enacted legislation prior to the OECD meeting, providing an overview of the global governance structures pertaining to gene edited agrifoods helps to add context to the brief discussions below. Regulatory frameworks address scientific and sanitary considerations related to gene edited products. Though the Cartagena Protocol defines GMOs as LMOs, policy interpretations of what constitutes a GMO vary widely.³ The arrival of gene editing in the biotechnology sphere has not necessarily resulted in opening a significant new approach to regulation, but rather entails addressing biosafety concerns within existing frameworks. In this section we discuss the roles of various international organizations in the governance of gene edited agrifoods.

Figure 3.1 shows the major actors in the global governance space and demonstrates how these actors interact with one another. The organizations’ mandates fall under two main areas: those covering sanitary and phytosanitary protections,⁴ and those covering sociotechnical and economic policies.⁵ However, the interactions of organizations are not limited to those in the same category. All the organizations in Fig. 3.1 have some role in setting standards, developing consensus-based protocols, and facilitating global dialogue on the scientific, economic, and social implications of innovative technologies in the agrifood system. Countries are signatories to certain protocols, or members of organizations, such as the World Trade Organisation (WTO) and/or OECD. In terms of decision-making, the governance space is horizontally oriented, with multi-directional interactions between and amongst organizations. There are several international organizations that guide these decisions, depending on whether the country is a member/signatory and therefore subject to the organization’s regulations, guidelines and principles: the OECD, the World Trade Organisation (WTO), the Food and Agriculture Organisation/World Health Organisation’s (FAO/WHO) Codex Alimentarius standards and codes, the International Plant Protection Convention (IPPC), World Organisation for Animal Health (WOAH), the Cartagena Protocol on Biosafety (CPB).

Fig. 3.1

Governance of gene edited foods. (Adapted from FAO, 2022a)

The OECD is at the forefront of the global dialogue regarding gene edited agrifoods. It gathers stakeholders to assess change, and potential responses to changes. The OECD is the central hub in the governance network, that other organizations look to for policy guidance, data on policy development and socio-economic considerations related to gene edited agrifoods. The OECD works towards consensus-based policy considerations and standards setting for gene edited agrifoods. The OECD acts as an information clearing house and knowledge hub and is a valuable source of information for regulators. It has an ongoing working party made up of country representatives that has been discussing issues regarding harmonization in biotechnology, safety of novel food and feeds since 1982. The OECD working party guideline documents provide detailed content on issues covered by the other organizations, as discussed below (Friedrichs et al., 2019).

The most important international guidelines relating to the global governance of gene edited agrifoods are the Convention on Biological Diversity (CBD)⁶ and the Cartagena Protocol on Biosafety (CPB). The Cartagena Protocol on Biosafety to the Convention on Biological Diversity (a supplement to the CBD) was agreed upon in 2000, coming into force in 2003. It covers guidelines for risk assessments, environmental/biodiversity, and human health. Currently, the CPB has 173 signatories, most of which base the language used in their national regulations on the language in the Protocol. Its guidelines govern the transboundary movement of LMOs. The Nagoya Protocol (a supplementary agreement to the 1992 Convention on Biological Diversity) coined the definition for ‘Living Modified Organisms’ and ‘food derived from modern biotechnology’. The Nagoya Protocol is a legal framework that lays out predictable international access to local genome sources. These definitions are used to establish if the treaty and related domestic regulation apply to gene edited organisms.

The FAO/WHO have also established guidelines for gene edited agrifoods. Joint FAO/WHO Food Standards Programs such as the Codex Alimentarius Guidelines (Codex), define ‘modern biotechnology’ based on the CPB definition, but have not adopted the CPB’s definition of LMOs that includes GMOs. The guidelines include references to food safety assessments, which include principles for risk assessment, for conduct of food safety, plants, animals, and microorganisms on labelling. The guidelines also include standards on analytic methods to evaluate products of biotechnology, and how to assess the equivalence of sanitary measures associated with food inspection and certification systems.

The International Plant Protection Convention (IPPC), an intergovernmental treaty established in 1951 and overseen by the United Nations, has been ratified by 184 countries. It includes standards and procedures for identifying pests that threaten plant health, assessing risk, and determining the strength of regulatory measures to limit unintended spread of pests, invasive species, etc. Most countries have guidelines to assess risks of pests that threaten plant health.

In terms of differences in national regulations that impede international trade, the SPS (Sanitary-Phytosanitary Agreement) of the WTO includes agreement on the use of scientific principles as the basis of SPS measures that restrict trade for the protection of plant, human, and animal health. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets out standards for the protection of intellectual property, including patents, trademarks, geographical indications, and copyright (WTO, 1994). The World Intellectual Property Organization (WIPO) administers treaties on intellectual property, which is a prime concern in the increasingly complex mix of biotechnology techniques and applications. But ultimately, each national framework for gene edited agrifoods is autonomous. Signatory countries are obliged to abide by the protocols and agreements they sign, but how standards and principles are enforced is largely up to the state-level governing bodies.⁷

Soon after the discovery of CRISPR-Cas9 in 2012, there were many questions raised about this novel gene editing technique and about CRISPR’s impact on plant breeding, and national security (e.g., CRISPR’s potential use in biological warfare), and how to regulate it. The increasing experimentation with CRISPR-Cas9 in agrifood raised questions in many jurisdictions about how to regulate this novel technique, necessitating the OECD meeting in 2018. Policy makers were trying to build some consensus on whether to use their respective countries’ pre-existing national regulatory frameworks covering GMOs, or to develop a different policy framework to accommodate agricultural biotechnology techniques that do not use foreign DNA (SDN1 and SDN2) and are not considered transgenic. Regulators were then faced with, what Asquer and Krachkovkaya (2021: 1114) refer to, as ‘response uncertainty’. Response uncertainty, “…arises from the inability to predict, which regulatory tools are more suitable to the specific features of the emerging technology.” Response uncertainties include considerations over whether restrictive regulations limit R&D, innovation, and domestic business or whether permissive regulations could result in unintended consequences, risks to health and safety and/or harms to humans, animals and/or the environment (Asquer & Krachkovskaya, 2021). As discussed in the next section, there have been several ways regulatory frameworks have responded to the response uncertainty presented by CRISPR-Cas9.

3 State-Level Regulatory frameworks for Gene Edited Foods

Countries have taken different paths towards regulating gene edited agrifoods. Figuring out the right way to combine the benefits of innovation, economic development, health and safety, and social license is a difficult task, especially when the functions of nucleases that can edit the genome to achieve desirable traits are discovered every year. Some countries have been influenced by the positions taken by neighbouring countries in their geographic regions and by their trading partners. Others are in the midst of crafting their regulatory frameworks, seeking guidance from regulators in other jurisdictions who have experience with developing standards and protocols. A third group of countries are currently developing regulatory frameworks for all forms of biotechnology in agriculture, covering GMOs and gene edited agrifoods where none existed before, as is the case for several developing countries across Africa. There is also a host of countries that have no publicized regulations, and no active policy discussions.

Here, we briefly discuss the five general categories of regulatory protocols for gene edited agrifoods that countries fall into: lightly regulated, strongly regulated/prohibited, proposed regulation, modified process, and no regulations/no active policy discussions. Table 3.1 outlines in detail where 53 countries fall in terms of whether they are signatories of the CPB, the date of the first regulatory decision regarding gene editing, and the type of regulation. Table 3.1 also categorizes each country into whether it follows a ‘product’ or ‘process’ based regulatory approach. The product-based approach is premised on the idea that the ‘risks posed by agrifoods are a function of biological characteristics and the specific genes that have been used,’ while the process-based approach to evaluating the risks posed by products of biotechnology are based on ‘processes employed in their development’ (Tagliabue, 2017: 3; Prakash et al., 2014). Information is not readily available for all countries, nevertheless, the Table provides a reference point for the discussions in this chapter. Table 3.1 summarizes the regulatory landscape for gene edited crops across countries as of early 2024.

Table 3.1 The regulatory landscape for gene edited crops

Generally speaking, Site Directed Nucleases interventions, where foreign DNA is inserted into a host genome (SDN3), are considered GMO (transgenics) (Sprink et al., 2016). These are considered ‘novel combinations of genetic material’, the language used in the CPB’s definition of LMO. This wording is used in some national regulations to define GMOs. As discussed in Chap. 2 (Sect. 2.2.1), SDN1 does not use foreign genes to create edits. It harnesses the natural repair mechanisms that exist in the organism’s cell. It has similarities to the general mechanisms and results of breeding techniques that involve chemical or radiological mutagenesis. Because of different classifications of techniques, there are different views on how each technique should be appropriately regulated. There are different opinions on how each SDN technique should be defined in regulations. Some argue that SDN1 does not meet the legal definition of LMO/GMO because there are no foreign genes inserted into the genome, such as in the case of Canada. Others, such as the European Union, consider SDN1 techniques as products of ‘modern biotechnology’ and therefore having the same risk profile as GMOs (and are regulated as such). Some genome editing techniques were not discovered until after the establishment of biosafety regulatory frameworks in the 2000s. An update to regulation is then required to include the products that did not previously exist (Eriksson et al., 2019). Some have argued that it makes more scientific sense to move away from product vs. process-based definitions and evaluate the safety of the gene edited organism or products based on traits, creating a trait-based approach (Qaim, 2009; Gould et al., 2022). This approach has not yet been embraced by any one country.

Asquer and Krachkovskaya (2021: 1122) see global governance of CRISPR gene editing technologies as falling into two main camps: The EU approach and the US approach, with nuanced variations in the middle. They argue that the primary difference in how the EU and the US agencies responded to the advent of CRISPR as the dominant gene editing technique is that the EU interpreted the response uncertainty about CRISPR-Cas9 by subjecting the novel technique to existing regulatory frameworks rather than undertaking any institutional review and adjustments of regulatory practices. The EU is in the process of reviewing current Directives covering biotechnology as they apply to gene editing. The US chose the latter pathway (institutional review and adjustments of regulatory practices), as did other countries such as Canada and Australia.

Experts have developed many typologies to categorize regulatory frameworks for gene edited agrifoods (see Entine et al., 2021; Chou, 2023; Lawrence, 2023; Ahmad et al., 2021). But they all refer to five distinct approaches to regulating gene editing agrifoods: light regulation, strong regulation, proposed regulation, a modified process, and no regulation/policy discussions (see Table 3.1, column 4). Some countries are in the proposed regulation stage of development, and currently do not naturally fit into any of the above categories. As such, we have categorized them under separate headings (proposed regulations, no regulations/no active policy discussions).

Other systems of classification divide regulatory systems into process vs product-based forms of risk assessment (see Table 3.1, column 5). A product-based approach means that regulations are based on risk assessment of the product, regardless of the process by which products or organisms were developed, while in a process-based approach a different set of regulations applies depending on the process used (e.g. gene editing). According to Friedrichs (2019: 209), there are several jurisdictions using the ‘process-based’ model that are currently reviewing the scope of their definitions of whether gene edited agrifoods are regulated as GMOs or LMOs, including New Zealand, and the European Union. Product triggered regulatory systems, most notably Argentina, Brazil, Canada, and the United States consider the novelty of the trait on a case-by-case basis no matter what process was used to achieve the novel trait.

Figure 3.2 summarizes the current global regulatory environment for gene editing into five categories: light regulation, strongly regulated and/or prohibited, proposed regulation, modified process, and no regulations/active policy discussions.⁸

Fig. 3.2

Current regulatory environment for gene edited plants. (Adapted from Chou, 2023; Lawrence, 2023)

3.1 Light Regulation

The light regulation category includes countries that have defined GMO exemptions for gene edited agrifoods (See Fig. 3.2, green shading). The regulatory system differentiates between gene edited agrifoods and GMOs. Australia and New Zealand have harmonized their regulatory frameworks under the GMO regulation law. Food Standards Australia New Zealand (FSANZ) is an independent statutory authority that enforces the Australia New Zealand Food Standards Code (‘the Code’), which is a collection of enforceable food standards. They both use process as a trigger, however organisms using SDN1 are not considered GMOs. Australia amended its Gene Technology Regulations (2001) in 2019 which states that it will not regulate the use of gene editing techniques that do not introduce new genetic material (SDN1). SDN1 plants are no longer considered GMOs and are no longer regulated under the Gene Technology Act 2000 and are now regulated by the Department of Agriculture, Water and the Environment. Despite the shared governing responsibilities under the FSANZ of GMOs standards, however, New Zealand continues to evaluate the biosafety of gene edited plants the same as GMOs (Ahmad et al., 2021).

Japan applies a case-by-case methodology to any organism with novel traits applying for regulatory approval. The Ministry of Health, Labour and Welfare published final guidelines in 2020 (Laaninen, 2020). The Ministry of Environment determines whether the product falls outside of the scope of LMO. Gene edited agrifoods are not subject to GMO biosafety protocols if no foreign DNA is present in the final product. Japan has approved two agrifood products for commercialization: a GABA enriched tomato and sea bream fish were approved in 2021, which are both available to Japanese consumers (Menz et al., 2020: 14).

Nigeria’s Biosafety Management Agency has determined that if no foreign DNA is present in the organism, a non-GMO classification is given. Nigeria’s regulatory framework shares similarities with Argentina, Australia, Brazil, Colombia, Israel, Japan, and Paraguay (Entine et al., 2021: 565). Kenya’s National Biosafety Authority has indicated it will evaluate the biosafety of gene edited agrifoods on a case-by-case basis (Entine et al., 2021: 565). Final decisions will be based on the presence or absence of transgenes in the final product, which is similar to the framework introduced by Argentina in 2015 (Whelan & Lema, 2019).

Canada is also considered a ‘light’ regulator. It uses a product-based approach. Gene edited organisms are evaluated on a case-by-case basis but are not considered equivalent to GMOs with foreign DNA (Entine et al., 2021: 568). Section 3.4 provides a detailed discussion of the Canadian case. The United States, similar to Canada, takes a product-based approach to risk assessment, and finalized this into regulation in 2015. The United States Department of Agriculture (USDA), The Animal and Plant Health Inspection Service (APHIS), and the Food and Drug Agency (FDA) evaluate products for health and safety. Biosafety regulation is triggered by risk factors on a case-by-case basis. Regulatory frameworks are different for gene edited animals as opposed to plants. In 2020, a final rule updated and modernized the USDA biotechnology regulations under the Plant Protection Act. The ‘Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient’ (SECURE) rule “brings USDA’s plant biotechnology regulations into the twenty-first century by removing duplicative and antiquated processes in order to facilitate the development and availability of these technologies through a transparent, consistent, science based, and risk-proportionate regulatory system” (Laaninen, 2020: 8). The development of market-oriented traits, such as gene edited soybeans with higher levels of oleic acid, is led by the United States and China. The expectations the US has about future innovative technologies in agriculture largely informed how the regulatory system has responded to the growing popularity of CRISPR. This is what Asquer and Krachkovskaya (2021: 1122) refer to as the ‘anticipatory response’.

Several South and Central American countries share similar regulatory profiles. Argentina has commercially grown GM crops since 1996 and uses the Cartagena Protocol’s definition of LMO. The Ministry of Agriculture, Livestock and Fisheries evaluates applications on a case-by-case basis. Gene edited plants and animals are not considered GMOs because they do not have novel combinations of genetic material. After the Argentinian regulation was enacted, other Latin American countries developed their own set of regulations. Chile’s Agriculture and Livestock Service aligned with Argentina and passed similar biosafety regulations to Argentina’s in 2016. Paraguay (Ministry of Agriculture and Livestock, and Paraguay National Commission on Agriculture and Forestry Biosafety) shares some principles with Argentina. Both Colombia (Agriculture Institute) and Brazil enacted their legislation in 2018 (Whelan & Lema, 2019). The National Technology Biosafety Commission of Brazil shares similar approaches with Argentina and Chile. The regulatory framework goes further to include a list of techniques and genetic interventions that are not considered GMOs.

Paraguay, Ecuador, Honduras, and Guatemala passed their regulations in 2019. If foreign DNA is used in an organism, Ecuador’s regulatory agency views this as a GMO, excluding SDN1 and cisgenesis (Entine et al., 2021: 552). Guatemala and Honduras (Guatemala Ministry of Agriculture, Livestock and Foodstuff, and Honduran National Service of Agrifood Health and Safety, respectively) have harmonized their regulations for GMOs. The regulations are based on a specific definition for ‘novel combination of genetic material’ and final product characteristics compared with conventional breeding products, essentially a ‘case-by-case’ basis for evaluation.

Israel’s Plant Protection Services Administration takes a similar perspective on how gene edited plants are regulated. Plants without foreign DNA are classified as non-GMO as long as no foreign DNA is in the organism. Since leaving the EU, the United Kingdom (UK) has re-evaluated its regulatory stance on GMOs and is set to release updated guidelines. Part of the Genetic Technology (Precision Breeding) Act 2023, crops derived through precision breeding are no longer subject to the same regulations as GMOs in the UK. The Department of Environment, Food and Rural Affairs’ definition of a GMO excludes organisms that have genetic changes that could occur naturally or achieved through traditional breeding.

As Informant 17, a research scientist working for an NGO, stated with respect to where India falls in the regulatory typology,

where in most of the other countries, including India, ‘process’ is what is governing the GM definition.

There are many research programs and activities that are underway in India researching crop improvement using gene editing. India’s Ministry of Environment, Forest and Climate Change, and the Ministry of Science and Technology regulates plants with novel traits derived from SDN1 or SDN2 as exempt from GMO regulations (which cover products of biotechnology that used SDN3). The ministries are currently examining whether all new technologies should be regulated as per existing regulatory frameworks. When new crop varieties come up for assessment using gene editing the regulatory framework will have to be firmly in place (Tiwari et al., 2021). As of 2023, regulatory amendments are still in process, though India’s framework covering gene edited agrifoods closely adheres to the scope of other regulatory frameworks in the lightly regulated category.

Most recently, Bangladesh passed legislation for gene edited agrifoods in March 2024 that clearly places it in the lightly regulated category along with India. If applicants can demonstrate “… the absence of any exogenously introduced DNA and request confirmation through appropriate channels to register or release the plant following the same procedure as those used for conventionally bred counterparts” (Genetic Literacy Project, 2024a).

3.2 Strongly Regulated and Prohibited

This category includes countries that have regulatory systems that have no exceptions for gene edited agrifoods (see Fig. 3.2, purple shading). Gene edited foods are assessed for risk the same way as GMOs. There are several countries that have prohibited the environmental release and/or cultivation of GMOs and gene edited organisms. The EU via its EU Directive (Directive 01/18/EC) led by the European Food Safety Authority takes a precautionary approach. All organisms derived from mutagenesis are considered GMOs, however if mutagenesis is derived from conventional breeding techniques with a long history of safety it is exempt. The European Union is a global leader in gene editing research (but behind on market-oriented trait development), despite its strict policies (Modrzejewski et al., 2019).

Like the EU, Switzerland considers gene edited organisms as GMOs. In the EU, the advent of CRISPR-Cas9 in agrifood research triggered a regulatory response in the form of reaction by existing regulatory standards, what Asquer and Krachkovskaya (2021: 1123) refer to as a ‘consequential response’. This consisted of a reactive approach to technologies such as gene editing. In July 2023, the EU Commission publicized a proposed amendment to the Directive covering all products of biotechnology. New Genomic Techniques (NGT) plants are split into two categories: naturally occurring or by conventional breeding; all other NGT plants are treated as GMOs that require risk assessments and authorization. If the current proposal is accepted, it would lift regulatory burdens on some gene edited agrifoods. A fast-track approval process is proposed that would apply to the second category of plants if they are more tolerant to climate change or require less water or fertilizer. Though Norway is not part of the European Union, it shares a highly restrictive position towards gene edited agrifoods. GMOs and gene edited agrifoods are restricted from environmental release, though scientists in Norway are pressing for modified restrictions for organisms derived using SDN1 techniques. According to the Genetic Literacy Project, “Norway law also demands the assessment of three non-safety categories: social benefit, sustainable and ethically sound products”, going beyond its neighbouring EU regulations (Genetic Literacy Project, 2024b).

Mexico was on the pathway to establishing a product-based biosafety protocol, but reversed direction on gene edited agrifoods. Gene edited foods are evaluated based on the process and are considered equivalent to GMOs. Informant 10 (a research scientist) worked in Latin America on gene editing in agrifood and informed us that,

when the [current Mexican] government came into power [in 2018] …they reject everything. They reject biotechnology, whether it is GM, whether it is genetic editing, genome editing, anything that has a hint of biotechnology and a lab they reject.

In addition to Mexico’s current stance on gene edited agrifoods, Belize has a moratorium preventing gene edited organisms from release into the environment.

South Africa’s Department of Agriculture, Land Reform and Rural Development use a risk assessment framework for GMOs that would also apply to new breeding techniques such as gene editing. It has opted for a tiered approach to assessments. South Africa’s regulatory framework includes the EU-based definition for GMOs, which is somewhat divergent from how the Cartagena Protocol defines GMOs. Using phraseology such as “naturally occurring genetic variation” as a threshold to trigger biosafety protocols has garnered criticism, as has South Africa’s chosen definition of GMO (Entine et al., 2021: 566).

Though part of the FSANZ agreement with Australia as discussed in the previous section, New Zealand continues to define gene edited organisms as GMOs. In 2014, there were discussions regarding changing how gene edited agrifoods were regulated but this was not successful. New Zealand continues to regulate gene edited agrifoods under the Hazardous Substances and New Organisms Act under the Environmental Protection Authority (Ahmad et al., 2021).

3.3 Proposed Regulation

The countries in this category as of early 2024 were in the midst of finalizing their regulations for gene edited agrifoods (Fig. 3.2, orange shading). There are ongoing policy discussions and draft proposals currently under review. This category includes Burkina Faso, Ethiopia, Uganda, Zimbabwe, Taiwan, Vietnam, South Korea, El Salvador, Thailand, Russia, and Uruguay (Chou, 2023). Some countries in this category are leaning towards regulating gene edited agrifoods the same way as GMOs, while others are seeking a simplified assessment procedure.

According to Informant 19 (a private sector representative), there are open discussions among several sub-Saharan African countries regarding harmonization of regulatory frameworks for gene editing agrifoods. They explain:

The conversation is starting to happen on having a harmonized regulatory landscape. For example, Kenya, Uganda, Tanzania, South Sudan and a little bit of Rwanda. These conversations are happening since we trade closely with each other. Maybe it’s best for us to come up with a more regional regulatory framework for these emerging technologies. But I would say for now, it’s still fragmented. When you look at Kenya, for example, it could be a step ahead when it comes to genome editing and developing the regulatory framework for that innovation. And Uganda is still grappling with putting in place the regulatory framework for GMOs and so I would say countries are starting to have that conversation. But there’s no homogeneity in getting this to be operationalized. The concern is that it would help if regions had more harmonized regulatory frameworks. (Informant 19)

Costa Rica is also developing its own regulatory framework for gene edited agrifoods. The State Phytosanitary Service has procedures in place for determining whether a gene edited crop is considered a GMO. In November 2023, the country amended its biotechnology regulations to reduce barriers to common applications of modern biotechnology. It is expected that the first gene edited banana that is resistant to yield reducing fungal diseases will be on the market in Costa Rica by the end of 2024 (USDA, 2024). But as Informant 19 states, there are ongoing challenges for developing countries who are creating regulatory frameworks from scratch. They state:

…developing countries…there’s a challenge to have a regulatory landscape that is working for technologies that are pre-existing like genetic engineering. So before we even had closure on that, genome editing is coming in and it’s creating what you might call ‘a spanner in the works’ where some policy makers are like, ‘wait, wait, should we pause?’ Formulating the regulatory landscape for GMOs and consider how we can incorporate these imagined technologies. So there’s that challenge of whether to use existing regulatory frameworks for GMOs for genome editing or to completely start afresh with genome editing and because of that, it’s affecting the speed at which the genome edited products and innovations may benefit the intended end users. So that’s one of the key challenges I see, especially here in the developing world. (Informant 19)

The Russian government has invested substantially in gene editing research programs, according to Tiwari et al. (2021: 18) and initially planned to develop ten new varieties of gene edited crops. In 2019, a federal program was announced that included developing thirty new varieties of gene edited agrifoods by 2027 (Dobrovidova, 2019). The country has also prohibited the environmental release of GMOs and gene edited organisms; however, researchers have been allowed to experiment with these techniques for research purposes only as of 2016. Russia is currently running experiments using gene editing on barley, sugar beets, wheat, and potato. Russia is the largest producer of barley, and a leader in producing the other three crops. The announcement of funding for gene editing research into economically important crops for Russia raises some questions as to whether the regulatory framework will apply to these crops.

3.4 Modified Process

The most active country in genome editing research is China. However, it has not released any legal documents referencing its regulatory stance on gene editing organisms, but it is possible that China wants to have a product in hand before releasing regulations (Modrzejewski et al., 2019). China is also in the process of releasing its regulatory framework for gene edited agrifoods. However, its current legislation considers gene edited agrifoods GMOs, but with a simplified assessment procedure (‘GMO light’). The Ministry of Agriculture and Rural Affairs allows gene edited plants that are determined to not present biosafety risks or risks to human health to be subject to a simplified registration procedure. It is predicted that China will lean towards the case-by-case basis for gene edited agrifoods risk and safety assessments, similar to Canada and the US, but not identical.

3.5 No Regulations

There are countries that do not have regulations for GMOs and there are no active policy discussions pertaining to how gene edited agrifoods should be regulated. There are also countries that currently do not have regulatory frameworks covering GMOs or gene edited agrifoods: Myanmar, Sudan, North Korea, Pakistan, and Egypt. This does not mean that gene edited crops can be released into the environment under any conditions. It simply means that these countries do not have regulatory frameworks covering gene edited plants yet and that there are no current, active discussions occurring to develop a framework. Countries that do not have active policy discussions are shaded grey in Fig. 3.2.

The influence of more established, larger trading partners is also something to consider, as it comes up in many discussions of regulatory frameworks emerging in the developing world. The precautionary position of Europe has exerted considerable influence on the regulatory frameworks of its smaller trading partners in Africa and elsewhere. Because many African countries export products to the EU, which strictly regulates GMOs and gene edited agrifoods, regulators in countries dependent on trade with the EU have had to consider the implications of taking a more open approach to gene editing, that resembles Canada, Australia, or Argentina’s approaches. Informant 19, who engages with several African governments on genomic technologies in the agrifood system, has witnessed the strong influence the EU exerts on its African trading partners. They note:

…you see that much of what is happening in Africa, in sub-Saharan Africa, for example is influenced by Europe’s stand on the issue. If Europe is saying we are going to regulate edited products as GMOs that is going to have an effect on many countries in Africa and this is because of the complicated history of Europe and Africa…the biggest driver I see when it comes to the conversation on what regulatory frameworks should look like…Europe’s approach to this is going to have a ripple effect in much of Africa.

As we can see, there is a diversity of approaches to regulating gene edited agrifoods. Some countries, namely in the same geographic region, have developed regulations that harmonize with their neighbors, as in South and North America. Divergent regulatory approaches result from different social, economic, and political realities. Different approaches to gene edited agrifoods as either considering them equivalent to GMOs or defined as LMOs complicates trade relationships in the agrifood system. A globally harmonized regulatory framework and guidelines is one suggestion put forth by experts in order to maximize the economic (and environmental) benefits of gene edited crops (Entine et al., 2021: 552).

4 Case Study: Canada

Canada’s approach to regulating gene edited agrifoods has gained international praise for its focus on evaluating the end product rather than the techniques used in the plant breeding process. Therefore, it is worth delving a bit deeper into how the Canadian regulatory framework functions. For example, private sector representative Informant 8 stated that:

Canada’s regulatory approach, which is strongly supported by international science, going back, 20 years, focuses on the end result. When we’re talking about plant breeding, it’s the end result that matters.

Before we discuss how gene edited agricultural plants were declared to be ‘non-novel’ in the Canadian regulatory system in 2022, it is worth commenting on the basis for the Canadian gene editing policy position. The Government of Canada regulates plants, animal feed and human food separately under different sets of legislation. Therefore, the regulatory requirements are based on case-by-case evaluation of end products (the product-based approach). Table 3.2, modified from Friedrichs (2019: 212), shows how decision-making over particular agrifood products is divided up among the relevant agencies. The three agencies that are relevant to the discussion on gene edited agrifoods are the Canadian Food Inspection Agency (CFIA), Health Canada, and Agriculture and Agrifood Canada (AAFC). The table shows the regulatory agency, the regulations it enforces and what products are covered by the regulation.⁹

Table 3.2 Authority, regulations covering novel agrifoods in Canada

For this discussion, the roles of CFIA and Health Canada are of primary interest regarding gene edited agrifoods. In Canada, the decisions by Health Canada and CFIA regarding whether or not to treat an agrifood as novel is based on whether the product is considered a ‘plant with novel traits’ (PNT) in an agricultural context, or a novel food in the case of Health Canada.¹⁰ The CFIA evaluates all novel plants using a product trigger regardless of the technology used to develop the trait, such as agricultural crops or feed for livestock. Health Canada is responsible for evaluating the safety of novel foods meant to be directly consumed by Canadians, such as fresh fruit or packaged foods. The relevant novelty of the trait in question is considered on a case-by-case basis. Novelty is not exclusive to genetically engineered plants, but all includes plants that undergo some form of modification that do not have a previous record of safe use in the Canadian environment.

If a plant is declared to be a PNT, it must be put through a rigorous set of risk-assessment and biosafety procedures before it is declared ‘safe’ for unconfined environmental release and commercialization (non-novel). If it is declared to be a PNT, it then moves through the regulatory system by meeting certain biosafety protocols (see Fig. 3.3). Biosafety testing is based on scientific information and appropriate data relative to the environmental risk of the PNT compared to its counterparts established in the Canadian environment. Testing must show that the PNT, once released, is not able to comingle with native species of a similar genotype (gene flow) or become a weed (weediness), must have its pest potential tested, must not be toxic to humans and/or animals, and must not pose a threat to biodiversity (CFIA, 2023, Directive 2009-09). Each stage of the regulatory system is dictated by regulations set out in Directives (DIR). The series of Directives dictate the requirements a pending PNT must meet to be approved for unconfined environmental release. The Directives are vital parts of Canada’s product-based safety evaluation system for PNTs/novel foods (Clark & Phillips, 2013).

Fig. 3.3

Regulatory pathway for novel crops, foods and feeds in Canada

Figure 3.3 is a simplified decision-making tree for plants with novel traits/novel foods. As indicated in Fig. 3.3, Health Canada oversees the regulatory process for foods, with CFIA having responsibility for feeds or crops. In both cases, if the feed/crop/food is not considered novel no pre-market assessment is necessary, and the product proceeds to commercialization. For feed/crops considered novel, a series of steps include pre-submission meeting of relevant bodies, and pre-market assessments. For foods considered novel, Novel Food Guidelines apply, and pre-market submission assessments are required. If the plant with novel trait or the novel food does not satisfy risk and safety assessments, approval is not forthcoming. If risk and safety assessments are met, decisions are posted on the CFIA website (feed/crops), or Health Canada’s website (food) and commercialization is allowed. Feed/crops undergo variety registration and are listed in the Canadian Variety Transparency Seeds Database prior to commercialization.

PNTs are subjected to a very complex and detailed risk assessment process. Health Canada also has rigorous thresholds for what is considered novel and how a novel food is treated in the regulatory system. Considering the rigor of the regulatory system in place to assess PNTs, it is significant that both Health Canada and CFIA declared that gene edited plants are not considered novel simply because they are derived from gene editing. All agrifoods, regardless of how they are modified, are subject to equal scrutiny in the Canadian regulatory system on a case-by-case basis based on scientific evidence.

Health Canada published a scientific opinion on the regulation of gene edited agrifood products. In 2022, Health Canada’s Division 28 of the Food and Drug Regulations (Novel Foods) was amended to include that novel food products that do not have a history of safe use are subject to evaluation regardless of technique. It stated that “novel food products from any breeding technique that might represent a food safety hazard would require a food safety assessment, to be done according to domestic guidance based on the Codex Guidance framework for safety assessments of foods derived from biotechnology” (FAO, 2022a: 32). This decision was preceded by Health Canada’s scientific position in 2021 that determined a high amylopectin starch maize using an SDN1 technique was not considered a novel food product. It did not require pre-market safety assessment as a novel food. The rationale for this decision was that the product had the same phenotype as pre-existing commercial maize varieties with a similar spontaneous mutation and had a history of safe use as food and was therefore, not novel. The following year, a gene edited high oleic soybean was determined to be a novel food and was subject to a food safety assessment based on WHO/FAO expert consultations (FAO, 2022a: 32).

In May 2023, the CFIA announced its scientific position on gene edited agrifoods. In the updated Directive 2009-09 (Plants with novel traits registered under Part V of the Seeds Regulation: Guidelines for determining when to notify CFIA) Sect. 4.1 states:

It is the scientific opinion of the CFIA that gene editing technologies do not present any unique or specifically identifiable environmental or human health safety concerns as compared to other technologies of plant development. For this reason, gene edited plants are regulated using a product based approach, like any other product of plant breeding. Namely, it is the traits that a plant exhibits and whether these traits would have a significant negative impact on environmental safety that are used to determine whether a plant would be subject to Part V of the Seeds Regulations. (www.inspection.gc.ca). (CFIA, 2023)

This decision was made based on government consultations with stakeholders throughout the agriculture sector and science-based assessment of the safety and efficacy of gene editing techniques. As Informant 15 (a regulatory representative) stated,

…there’s been a real need for larger conversations across the sector. Not necessarily to change how something’s regulated, but to have an overall agricultural sector approach.

As of 2023, Canada is the only country to engage in multi-stakeholder consultations regarding the regulation and environmental release of gene edited agrifoods. In early 2023, the Government Technical Committee on Plant Breeding consulted with concerned stakeholders on potential issues that may arise with the introduction of gene edited seeds in the agrifood sector in Canada. The Committee focused on three primary areas of discussion: achieving transparency goals, establishing a governance structure to review effectiveness of transparency and government oversight, and discussing options for oversight of the Canadian Variety Transparency Database (AAFC, 2023).¹¹ When asked what issues arose during discussions among stakeholders, Informant 15 stated:

the need for a transparent and predictable regulatory pathway for products and gene editing. How a particular policy links into the larger framework and context that surrounds it. Whether that be public perception around new technologies or tools required to enable coexistence. And by that, I mean the use of different technologies side by side.

Marketplace transparency was at the forefront of consultations, as noted in the Chair’s Report to the Minister on the Industry-Government Technical Committee on Plant Breeding Innovation Policy (AAFC, 2023). The organic sector had concerns regarding how gene edited seeds will be identified in the agrifood system. The organic sector was concerned about how gene edited seeds would be segregated from conventional seeds (which the Canadian Organic Standards allows for use in organic agriculture if no organic varieties are available). Improved marketplace transparency in the sale of seed is paramount to ensure different types of agriculture can co-exist across Canada. Informant 8, a private sector representative who participated in these discussions surrounding the Canadian Variety Transparency Seeds Database, explained to us that:

Between January and March [2023] there was one forum, and that resulted in a report from the AAFC¹²…And one of the outcomes of that was that report made a number of recommendations… It’s a listing of registered crop variety in Canada, and it tells you whether they were developed using gene editing or not. One of their recommendations was that the database should remain free, and it should evolve over time and one of the recommendations was that AAFC should monitor and do some surveys of seed companies to make sure it’s accurate, and up to date. And then another recommendation was that … the ag sector and government continue to meet to monitor transparency as the first gene edited products are commercialized to make sure everybody’s needs are getting met and that group has met twice now. So, this is not a popular opinion, but I think it’s awesome. I never expected to be part of meetings where the organic sector sits down with tech developers, and they’re having a conversation.

Stakeholders such as CropLife Canada and Seeds Canada¹³ agreed to participate in the building and continued updating of the Canadian Variety Transparency Database (the ‘Seeds Database’) and Health Canada’s Transparency Initiative. The Seeds Database will be free, publicly accessible, regularly updated, reliable and user-friendly. The Technical Committee proposed that AAFC would be responsible for regular audits and conduct surveys with seed developers to confirm they are using the Seeds Database.¹⁴ Though this Database is not part of the regulatory scheme, stakeholders have committed to its creation and maintenance as a voluntary condition that needs to be met for co-existence to be possible in the Canadian agrifood sector and for trust in the regulatory system to be maintained. Seeds Canada is responsible for the Database’s operation and implementing improvements. Informant 15 said that the Canadian grain sector has much to gain from the Seeds Database as well as the organics sector:

I am not aware of any other country from which the seeds sector has put forward a voluntary transparency database. I think it’s unique to Canada…the need has come up through the organic sector looking to make sure that the seeds they buy are eligible for organic certification. But really, it’s also been a need identified by the grain sector as well.

Unlike in other jurisdictions, where the politics surrounding agricultural biotechnology has stalled or in some cases prevented the conversations from ever happening, transparency and deliberative discussions are the cornerstone of the Canadian model to increase stakeholder access to all the modern benefits of agricultural science, while avoiding imposing unnecessary costs on non-users. This approach is not without its challenges but has prioritized the economic health of the agricultural value chain in general above whether one approach to agriculture is considered superior to the other. All approaches to agrifood production have their benefits and drawbacks.

This is not to say that all stakeholders agree with how Health Canada, CFIA and AAFC have proceeded with regulating gene edited agrifoods. There is plenty of dissent. For example, representatives of the organic sector stated that transparency measures, in terms of gene edited seeds and the Seeds Database, do not go far enough to protect organic certification. The active participation of the organic sector in the proposed governance structures and oversight activities and ongoing consultations with plant breeders will hopefully live up to the expectations of all stakeholders in the agriculture sector (AAFC, 2023). But from a policy perspective, the path that the regulatory agencies have taken is one based on transparency, responsiveness, the principles of governance and above all, science-based risk assessments.

The result of the stakeholder consultations has helped inform the regulatory pathway for gene edited agrifoods in Canada. Some products developed using gene editing techniques may not meet the regulatory definition of ‘novel’. If not, a product is considered equivalent to its existing counterparts, and no pre-market assessment is required. Health Canada and CFIA have declared that gene edited agrifoods are not considered novel, and therefore not subject to the regulatory process for PNTs. This is the first step towards freeing gene edited foods from unnecessary regulatory burden, allowing for useful advancements in plant breeding and nutritional profiles of foods to be utilized, and getting us closer to solving some of the current supply chain problems plaguing the global agrifood system.

5 Conclusion

As new breeding techniques emerge, some are asking if new breeding techniques that do not include foreign DNA (SDN1) should be treated differently than GMOs or considered equivalent (in terms of risk assessment) as agrifoods from traditional breeding techniques. There are governance issues and questions regarding current and future novel breeding techniques and what types of consultation should be used. Canada has embraced the deliberative governance approach to gene edited agricultural plants. It has considered numerous stakeholders and their preferences, while trying to create a transparent regulatory framework. Risk and innovation need to be balanced to provide opportunity and benefits to all stakeholders—businesses and citizens. But risks to human, plant, animal, or environmental health must be given priority. How the level of risk is determined is what is often at odds in different countries. Moving forward, what appears to be central to effective regulation of commercialized gene edited agrifoods is working on communication exchanges among all stakeholders regarding policy objectives that balance precaution with facilitating innovative gene editing agrifoods.

One of the challenges of rapid advancement of techniques and gene edited organisms is that regulatory systems may struggle to keep up with the demand for regulatory approval. This may overwhelm understaffed and under resourced regulatory systems, compromising efforts to be transparent and inclusive in decision making and risk analysis. “Science cannot settle normative questions or determine policy judgements and decisions about regulating genetic engineering merely on its own assumptions, as both values and interests jointly contribute to framing social choices about the data to be acquired, analyzed and interpreted” (Leone, 2019).

Informant 5 (a research scientist) shares a similar perspective. The knowledge deficit model approach to deliberative governance and innovative technologies (manufactured risks) cannot make definitive conclusions on normative values applied to science. Informant 5’s position is that:

I’m not one of those people [who] believes that you have to convince people…you have to get them to accept the science, to accept the judgment. What they need to do is have some faith and trust and understanding that that the things that matter are dealt with…Nobody has to agree on the science. They just have to say, this is a legitimate and appropriate policy. Science never tells you what to do. Science just gives you the choices and the costs and benefits, and the trade offs.

This not only applies to gene edited agrifoods, but several innovative technologies such as vaccines that garnered vigorous public debate about the legitimacy of the science behind them.