1 International and National Legal Frameworks for Biosafety

Biotechnology products, such as LMOs and GMOs, are subject to regulation. Rules to regulate the safe use of LMOs and GMOs are established under international and national biosafety law.

For instance, the Convention on Biological Diversity (CBD) requires in Art. 8(g) that Parties “to establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health”.

In addition to the obligation pertaining to national biosafety systems, the Cartagena Protocol on Biosafety (CPB), a subsequent protocol to the CBD, governs the transboundary movements of LMOs [1].

According to Art. 1 CPB, the objective to the CPB is: “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”.

The CPB was adopted in 2000 and entered into force in 2003 [2]. Currently, 173 countries are Parties to the CPB. This means that such countries have either ratified, accepted, approved or accessed the CPB [3]. It is relevant to note that most Parties to the CPB are located in the Global South. In fact, both the text of the CPB and its adoption by jurisdictions in the Global South were promoted by influential actors in the Global North such as the European Union. In fact, the CPB stipulations were contested by other Global North prominent actors in the international environmental system, such as the United States of America [4].

According to Art. 2 CPB, CPB’s Parties are required to, inter alia, adopt national legal measures to implement their obligations under the CPB. Since the ratification of the CBD and the CPB, an increasing number of Parties have adopted domestic measures to govern the use of the LMO and to implement the CPB.

With the adoption of the CPB in 2000, some Parties to the CPB rapidly started to adopt national legislation to regulate the use of LMOs within their territories [5]. In the Global South, some countries have adopted a national biosafety legislation to govern LMOs. For example, in 2007, Malaysia adopted the Biosafety Act No. 678 to, inter alia, regulate the use of LMOs with the objectives of protecting human, plant and animal health, the environment and biological diversity. Similarly, in 2015, Dominican Republic adopted the Law No. 219-15 regarding the safety of biotechnology to ensure safe use of LMOs and prevent adverse effects that they could cause to biodiversity, human health and the environment.

Other countries in the Global South, which are also Parties to the CPB, have designed biosafety laws to regulate the safe use of GMOs. These countries regulate GMOs instead of LMOs. For instance, in 2005, Mexico enacted the Biosafety Law of Genetically Modified Organisms with the purpose of regulating various activities of GMOs to prevent, avoid or reduce the possible risks that these activities might entail to human health, environment and biological diversity. Similarly, in 2009, Kenya adopted the Biosafety Act No. 2 to facilitate responsible research into, and minimize the risks that may be posed by the GMOs to human health and the environment. Therefore, regardless the ratification of the CPB, some Parties have opted to use the term GMO, instead of LMOs, to design national measures to implement the CPB.

In the Global South, biotechnology products have been subject to regulatory oversight even before the adoption of the CPB. For instance, in 1999, Peru enacted the Law No. 27104 to prevent risks associated with the use of biotechnology and to protect the human health, the environment and biodiversity by regulating, managing and controlling the risks associated with LMOs. Similarly, in 1997, South Africa adopted the Genetically Modified Organism Act No. 15 to promote the responsible development, production, and use of GMOs to limit possible harmful consequences to the environment.

However, not all countries in the Global South have a biosafety legal framework to govern LMOs or GMOs. In fact, in the Global South, the purpose to adopt biosafety policies, legislation and regulations is diverse. For instance, most countries have adopted biosafety legal frameworks as an end product of the ratification and entry into force of the CPB [5, 6]. Other countries, such as Argentina and Brazil are major exporters of agrobiotechnology commodities, and this may be a contributing element to their advanced level of trade-related biosafety frameworks [7, 8]. Some other countries have opted to design biosafety policies to restrict the use of biotechnology products or have yet to promulgate any biosafety legal instrument [5]. Clearly, the economic importance of the agricultural sector and the role of biotechnology in each country are fundamental triggers for the rapid adoption of biosafety policies and laws [7]. Additionally, political will would be a key factor in the success of adoption biosafety policies and legislation [5].

Overall, some countries are designing bills of legal instruments to regulate LMOs, or GMOs, and implement the CBD and the CPB at a national level. For example, most Small Island States in the Caribbean, and the Pacific, are drafting biosafety legal measures [5]. Similarly, most Least Developed countries in Africa lack biosafety legislation [9].

2 What Is a Living Modified Organism (LMO)?

The term LMO has a universal legal definition that has been described under international environmental law. The concept of LMO was initially introduced in international law by the CBD in 1992 [10]. Two articles under the CBD presented the notion of LMO.

Firstly, Art. 8(g) CBD, concerning in situ conservation, indicates that each contracting party shall, as far as possible and as appropriate, “establish or maintain means to regulate, manage or control the risks associated with the use and release of Living Modified Organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health”.

Second, the concept of LMO is also presented in Art. 19(3) CBD referring to handling of biotechnology and distribution of its benefits. Art. 19(3) CBD notes that “the Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any Living Modified Organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity”.

The CBD only mentions the notion of LMO with the aim to develop appropriate measures to control their possible risks to biodiversity and human health. However, the definition of LMO is subsequently clarified in the CPB in 2003. According to Art. 3(g) CPB, a LMO refers to “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology”.

Some Parties to the CPB have included the legal definition of LMO into their national biosafety legislation [11, 12].

Activity 26.1: Adoption of the LMO Definition Under National Laws

  • Which other Parties to the CPB have adopted the LMO definition in their national biosafety law?

  • Are there non-Parties to the CPB that also follow the LMO definition?

3 Key Features of the LMO Definition

Based on Art. 3(g) CPB, the LMO definition contains three key features. A product is considered to be a LMO when it owns all these three characteristics:

  • Be a living organism,

  • Possess a novel combination of genetic material, and,

  • Be developed by the use of modern biotechnology.

Each feature of the LMO definition includes relevant legal terms that have also been defined under international law. Overall, the LMO definition contains four legal terms that are described by international law. These are: “living organism”, “genetic material”, “biotechnology” and “modern biotechnology”.

3.1 What Is a Living Organism?

According to the LMO definition of the CPB, LMO are living organisms. Art. 3(h) CPB defines the concept of living organism as “any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids”. According to this definition, a living organism possesses two joint characteristics.

Firstly, a living organism is any biological entity, including sterile organisms, virus and viroids. Living organisms are alive beings which are also referred to as biological entities, living beings, living systems or natural entities [13]. They occur in various forms [14]. For example, animals (including human beings), plants, bacteria, protozoa and fungi are living organisms [15].

Furthermore, entities such as sterile organisms, viruses and viroids are also included as living organisms according to Art. 3(h) CPB. It is noteworthy that some viruses and viroids are not alive entities [10]. However, the definition of living organisms, as stipulated by Art. 3(h) CPB, is broad as it includes non-living things, such as viruses and viroids.

Secondly, a living organism must be capable of transferring or replicating genetic material. Biological entities possess various capacities, including the ability to transfer or replicate their genetic material [13]. Similarly, viruses and viroids also possess this ability [10].

3.2 What Is a Novel Combination of Genetic Material?

Based on the LMO definition of the CPB, a LMO has to possess a novel combination of genetic material. However, there is no definition of the concept of novel combination of genetic material under international law. Rather, the term genetic material is in:

  • Art. 2 CBD, genetic material refers to “any material of plant, animal, microbial or other origin containing functional units of heredity”. Similarly, Art. 2 International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) defines genetic material as: “any material of plant origin, including reproductive and vegetative propagating material, containing functional units of heredity”.

Overall, the definition of genetic material by the CBD is broad, as it encompasses any genetic material of various types of living organisms, including plants, animals or microbes. In contrast, the definition of the ITPGRFA exclusively refers to genetic material of plant origin. However, both definitions agree that genetic material must contain functional units of heredity, which are composed of nucleic acids, such deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) carrying genetic information or genes [10, 16].

3.3 What Is Modern Biotechnology?

Before explaining the concept of modern biotechnology, it is relevant to describe what biotechnology means. Art. 2 CBD defines biotechnology as “any technological application that uses biological systems, living organisms, or derivates thereof, to make or modify products or processes for specific use”.

The term biotechnology was first introduced by natural sciences in 1919 to refer the scientific methodologies that allow products to be developed from raw materials with the support of living organisms [17]. For instance, biotechnology is used for the selective breeding of plants and animals or the use of microorganisms in the production of beer, bread and wine [18].

Modern biotechnology is one type of biotechnology. According to Art. 3(i) CPB, modern biotechnology refers to the application of “in vitro nucleic acid techniques, including recombinant DNA (rDNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection”. Both, in vitro nucleic acid techniques and cell fusion are primarily used for agriculture, textile, food and feed production, including the development of LMOs [19].

Additionally, the definition of modern biotechnology makes reference that these techniques are not same as methods used in traditional breeding and selection. However, the meaning of traditional breeding and selection is not defined under international law. Conventional, traditional, or natural could refer to traditional breeding and selection techniques, such as natural selection, cross-breeding, protoplast fusion, and chemical- or radiation-induced mutation [20]. These techniques modify the genetic material within the crossable gene pool of a species, but they do not introduce genetic information from other organisms [20].

4 What Is a Genetically Modified Organism (GMO)?

There is no international legal definition of GMO. Instead, the term GMO is introduced and defined only under domestic and regional law in certain jurisdictions. As such, some countries have designed their own definition of GMO, which is incorporated into their national biosafety laws. For instance, in the Global South, biosafety legislations in selected countries in Africa, Asia and Latin America and the Caribbean use the term GMO instead of LMOs (Table 26.1). It is relevant to note that, regardless the ratification to the CPB, some Parties to the CPB have decided to use the term GMO instead of LMO.

Table 26.1 GMO definition under national biosafety laws in certain jurisdictions
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As shown in Table 26.1, the definition of GMO varies between jurisdictions. Therefore, it is not possible to describe main characteristics of the GMO definition that can be universally valid. This is because there is no standard definition of the term GMO. In fact, the GMO definition contains different or similar features among countries with a biosafety law to regulate GMOs. Interestingly, these features of the GMO definition can be similar or different in comparison to the LMO definition of the CPB. Overall, the GMO definition can be equal, similar or different to the LMO definition.

First, for some countries with a biosafety law to regulate GMOs, the definition of GMOs is equal to the LMO definition of the CPB. This phenomenon occurs when revising biosafety laws in The Philippines and El Salvador. In fact, under such legislation, there is a clear indication that GMO is a synonym of the term LMO under the CPB.

Second, for other countries that have adopted a biosafety law of GMOs, the term GMO is very similar to the LMO definition of the CPB. the GMO concept under biosafety legislation of GMOs in Mexico, Nigeria and Kenya contains almost all the features of the LMO definition. For example, according to these laws, a GMO has to possess a novel combination of genetic material and have to be developed through the use of modern biotechnology.

Third, biosafety legislation in some other countries have design a GMO definition that is very different to the concept of LMO. This occurs in countries such as Brazil, Panama, South Africa and Vietnam. Here, there is no indication of modern biotechnology; instead, other scientific terms are mentioned such as genetic engineering, gene transfer technology or in a way that does not occur naturally. Similarly, these legal instruments only mention that the genetic material of the GMO has to be altered or modified. There is no reference that GMO has to possess a novel combination of genetic material.

Activity 26.2: Adoption of the GMO Definition Under National Laws

  • Which other Parties to the CPB have designed a GMO definition?

  • Are there non-Parties to the CPB that follow a GMO definition?

  • Which are the similarities or differences between the GMO definition of such countries and the LMO definition?

5 Regulatory Approaches Governing Precision Breeding

Under international law, there is no binding specific provision to regulate precision breeding or new breeding techniques. Some international organizations including the Secretariat to the CBD, Organization Economic Cooperation and Development (OECD), Food and Agriculture Organization of the United Nations (FAO) have made efforts to support countries when defining what precision breeding refers to. For instance, these organizations have designed guidelines to explain some precision breeding or other related techniques such as genome editing, synthetic biology and/or gene drive systems [21,22,23]. However, the definitions proposed by these organizations are not legally binding as those concepts have been developed as guidance only.

However, under national law, rules to regulate some techniques that could be placed under the umbrella term precision breeding exist. Recently, few countries, including in the Global South, with a biosafety legislation of LMOs or GMOs have adopted a new regulation to clarify the regulatory status of precision breeding [24] (Fig. 26.1). Interestingly, most of these countries are located in Latin America and the Caribbean region.

Fig. 26.1
A World map marks 13 countries that have adopted new rules to clarify the regulatory status of precision breeding. The countries are namely Guatemala, Honduras, Colombia, Ecuador, Chile, Brazil, Paraguay, Argentina, Nigeria, Kenya, India, and the Philippines. South Africa has adopted another approach.

Overview of countries in the Global South with a regulation or guidelines to regulate some technologies of precision breeding. Countries in yellow have designed a similar approach to regulate precision breeding products. Whereas countries in blue opted to adopt other type of approach

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Overall, 13 countries have designed guidelines or regulations that have been adopted in certain countries in the Global South (Table 26.2). The development of these guidelines and regulations results is a consequence that some precision breeding techniques can generate products that can be classified as LMOs or GMOs under biosafety legislation and they can result in organisms that can also occur in nature or through conventional breeding.

Table 26.2 Regulations governing precision breeding in selected countries
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Regulations in most of these countries acknowledge the fact that some precision breeding techniques could develop LMOs or GMOs, while others may not. Therefore, the purpose of these regulations is to develop an administrative procedure, and an application form for applicants to query to the National Competent Authority (NCA) whether or not their products are considered as LMOs or GMOs. The NCAs in these countries are:

  • In Africa: National Biosafety Authority in Kenya and National Biosafety Management Agency in Nigeria;

  • In Asia: Department of Biotechnology under the Ministry of Science and Technology in India and Department of Agriculture in The Philippines; and,

  • In Latin America and the Caribbean: Ministry of Agriculture, Livestock and Fisheries in Argentina, National Biosafety Technical Commission in Brazil, Service for Agriculture and Livestock in Chile, Colombian Institute of Agriculture and Livestock in Colombia, Ministry of Environment in Ecuador, Ministry of Agriculture and Livestock in Paraguay, Ministry of Agriculture, Livestock and Food in Guatemala and National Service of Agri-Food Health and Quality in Honduras.

Overall, according to [7], the applications forms that are developed by the NCAs request the following information including:

  • data about the parental organism, such as its molecular biology and phenotype,

  • the breeding methodology used to obtain and select the crop including the new trait or introduced characteristic, and an indication of the modified DNA sequences,

  • evidence of stably inherited genetic changes in the final product, including technologies used to discard a stably inserted new combination of, or foreign, genetic material in the final organism.

The NCAs in these countries analyze the information provided by the applicant and evaluate whether the products have a novel combination of genetic material or not. If the final organism has a novel combination of genetic material, it is considered as LMO or GMOs, and falls under the biosafety regulatory oversight [7, 12, 25].

Therefore, a common definition in most of these countries is what constitutes a novel combination of genetic material. This is because for all countries in Fig. 26.1 (in yellow), excluding South Africa, precision breeding products that lack a novel combination, or foreign, of genetic material are not defined as LMOs, or GMOs, according to their national biosafety legislation. The presence of novel combination, foreign or exogenous, of genetic material in the final product is the main consideration to classify a product as a LMO or GMO. Clearly, the characteristics of this definition may slightly or significantly vary between countries as indicated in Table 26.2.

To the contrary, the NCA of South Africa, the Executive Council for Genetically Modified Organisms in South Africa, had adopted a communication indicating that all products derived from new breeding techniques will be subject to regulation. Therefore, all products of new breeding techniques will be treated similarly to GMOs, and they will fall under subject to the Genetically Modified Organism Act No. 15 of 1997.

Some other countries in the Global South are currently discussing the need to adopt regulations for precision breeding or are designing drafts of guidelines to regulate precision breeding products. For example, this occurs in various countries in Latin America and the Caribbean [7]. Similarly, few countries in South East Asia are discussing whether or not regulate precision breeding products [26]. Additionally, ongoing discussions are taking place in some West African countries [27].

Activity 26.3: Approval of Regulations Concerning Precision Breeding

  • Which other Parties to the CPB have adopted regulations concerning precision breeding?

  • Are there non-Parties to the CPB that have design precision breeding regulations?

  • What is the trigger to regulate precision breeding countries in these countries?

6 Future Regulatory Perspectives on Precision Breeding

Some countries in the Global South, especially countries in Latin America and the Caribbean region, have designed regulations to assess the regulatory status of some precision breeding techniques. In fact, these countries have an extensive experience governing LMOs and/or GMOs since the 90s. Additionally, these countries are major producers of agricultural and biotechnological commodities [5]. As such, it was expected that these countries would rapidly adopt such new measures on precision breeding, as they have an interest to insert such these products into national and international markets. Clearly, the rapid adoption of procedures relevant to precision breeding is strongly linked to the role of agriculture and biotechnology in the countries and with national economic, social and political perspectives [7]. As such, it is likely that other countries with a similar attitude would likely be willing to adopt similar or slightly similar regulations on precision breeding.

However, countries in the Global South have diverse positions in terms of biosafety law and the role of agrobiotechnology in their economies. Countries that rely in other types of agriculture, e.g. organic, or have developed bans to the use of biotechnology products for agriculture would continue excluding the governance of precision breeding products. This is simply because precision breeding products are one alternative that can be utilized by certain countries but not necessarily the only one that can be used across all countries in the Global South.

It is fundamental to highlight the right of sovereignty of countries over their territory. For the Global South, clearly, there is no one-size-fits-all approach to promote the use of precision breeding in all countries. Nor all countries should follow a singular and common approach to govern precision breeding products. This would occur only when such approaches, if relevant and needed, fit the conditions and national interest of the countries about precision breeding.

Specially in the Global South, countries are complex actors and their socio-political and economic context and priorities would play a key role when deciding to what extent the adoption of regulation of precision breeding is relevant or not. For instance, countries that currently lack a biosafety regulatory system to assess the use of LMOs or GMOs such as Small Island States or most Least Developed Countries in Africa would probably, in the future, also lack precision breeding regulations as such matter is not a key priority for these countries. Clearly, this phenomenon could obviously change over time.

7 Summary

In the Global South, 13 nations have adopted regulations or guidelines to govern some precision breeding techniques. Most of these countries have designed a similar approach to assess the regulatory status of precision breeding products. The main criterion for such countries is whether or not the final product contains a novel combination of genetic material. To this aim, countries have designed a concept to legally define what novel combination of genetic material refers to. Such definition may vary or may be similar among nations.

However, overall, most jurisdictions in the Global South require legal clarity about whether products or organisms derived from precision breeding would be subject to biosafety regulation. For such countries, it is still not clear whether precision breeding products would be classified as LMO or GMOs, and therefore be subject to regulatory oversight under biosafety laws. Further studies are required to explore the interest or current developments of such countries to design regulations or guidelines to regulate some precision breeding techniques.

This section provided an overview of key definitions under international and national legislation to clarify the regulatory status of precision breeding products. This was done by assessing provisions under the CPB and national biosafety laws in selected countries in the Global South. This hopefully would aim to provide a baseline and a global perspective for further discussion about the regulatory status of precision breeding in other nations.

8 Further Reading

For a detailed overview of the LMO definition see [10] and revise the CPB. With regards to the GMO definition, read the national biosafety legislation and regulations of GMOs of the country of interest. Such legal instruments are available in the national gazettes or official journals of each country.