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Genetic modification (GM) is a technology that involves inserting DNA into the genome of an organism, giving it new or different characteristics. Genetically modified organisms are plants/livestock whose genomes have been engineered in the laboratory to favor the expression of desired physiological traits or the generation of desired biological products.

Traditionally genetic modification was achieved through selective breeding. This is when a select species of livestock, crops, and even pets are bred together to produce offspring that have desirable traits. In modern genetic modification, however, various genetic technologies are employed to produce organisms whose genomes have been precisely altered at the molecular level, usually by the inclusion of genes from unrelated species of organisms that code for traits that would not be obtained easily through conventional selective breeding.

In this article we will examine the global gene modification regulations for genetically modified agri-products, the regulatory bodies in charge, and the future trends and concerns regarding the regulation of existing and future GM crops to global food security. 

How Gene Modification Works

Genetic modification (also called genetic engineering) is a process that uses laboratory-based technologies to alter the DNA makeup of an organism. 

Source: The Royal Society 

There are two major scientific methods used to produce genetically modified organisms (GMOs) they are recombinant DNA technology and reproductive cloning. 

In reproductive cloning, a nucleus is extracted from a cell of the individual to be cloned and is inserted into the enucleated cytoplasm of a host egg (an enucleated egg is an egg cell that has had its nucleus removed). The process produces an offspring that is genetically identical to the donor individual. The first animal generated using this cloning procedure containing a nucleus from an adult donor cell (rather than a donor embryo) was a sheep named Dolly, born in 1996. Since then, reproductive cloning technology has been used to produce a variety of other species, including pigs, horses, and dogs.

Recombinant DNA technology, on the other hand, involves the combination of DNA molecules from two different species. This can include inserting a gene from one organism into the DNA of another, or combining two DNA molecules and inserting them into a host organism to create a new genetically modified organism. 

Basic Stages of Genetic Modification 

According to the Food and Agriculture Organisation(FAO), there are 9 general stages of creating genetically modified organisms (GMOs) They include:

Stage 1-4

• Identification of the gene of interest: Scientists find a specific gene in an organism that has a trait they want to use, like resistance to pests or drought. This gene is what gives the organism its special ability.
• Isolation of the gene of interest: The gene identified is then carefully separated from the rest of the organism’s DNA. This is similar to picking out a single piece from a puzzle.
• Amplifying the gene: Once the gene is isolated, scientists make many copies of it using a technique called PCR (Polymerase Chain Reaction) so they have enough to work with.
• Associating the gene with an appropriate promoter and poly A sequence and inserting it into plasmids: To make sure the gene works properly in the new organism, scientists attach it to a promoter (which acts like an “on” switch) and a poly A sequence (which helps the gene function smoothly). They then place this whole setup into a plasmid, a small circular DNA piece that can carry the gene into the new organism.

Stage 4-9

• Multiplying the plasmid in bacteria and recovering the cloned construct for injection: The plasmid, now carrying the gene, is placed into bacteria. The bacteria multiply, creating many copies of the plasmid. 
• Transferring the construct into the recipient tissue, usually fertilised eggs: The gene-carrying plasmid is injected into the cells of the target organism, often at the stage of a fertilised egg. This allows the new gene to be present from the very start of the organism’s development.
• Integration of the gene into the recipient genome: The new gene is inserted into the DNA of the target organism, becoming a permanent part of its genetic code. 
• Expression of the gene in the recipient genome: The organism starts using the new gene to produce proteins, which result in the desired trait, such as pest resistance or faster growth.
• Inheritance of the gene through further generations: As the genetically modified organism reproduces, it passes the new gene to its offspring, ensuring the trait continues in future generations.

Examples of GM Crops and Their Traits

Genetically Conferred Trait	Example Organism	Genetic Change
APPROVED COMMERCIAL PRODUCTS
Herbicide tolerance	Soybean	Glyphosate herbicide (Roundup) tolerance conferred by expression of a glyphosate-tolerant form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) isolated from the soil bacterium Agrobacterium tumefaciens, strain CP4
Insect resistance	Corn	Resistance to insect pests, specifically the European corn borer, through expression of the insecticidal protein Cry1Ab from Bacillus thuringiensis
Altered fatty acid composition	Canola	High laurate levels achieved by inserting the gene for ACP thioesterase from the California bay tree Umbellularia californica
Virus resistance	Plum	Resistance to plum pox virus conferred by insertion of a coat protein (CP) gene from the virus

Gene Modification Regulations Globally 

To determine the global regulatory landscape, we will focus on the regulations of some of the top GM crop-producing regions which include the United States, Canada, and the European Union. Each country’s gene modification regulations standpoint was examined to determine the factors that allowed them to cultivate GM crops on large scales.

One important consideration is whether the region’s gene modification regulations are process or product-oriented. Process-oriented laws view GM technologies as a novel approach in comparison to traditional methods, whereas product-oriented regulations focus on the product’s novel qualities in comparison to those produced by conventional breeding. Each has advantages and disadvantages, but neither can be deemed superior.

The European Union GM Regulations

The European Union (EU) has strict gene modification regulations in place to manage the use of genetically modified organisms (GMOs). These regulations aim to ensure the safety of human health, animal health, and the environment.

The primary regulation that governs GMOs in the EU is Regulation (EC) No. 1829/2003. This regulation sets the framework for the authorisation of GM food and feed within the EU. Its main goal is to ensure that any GMO-related products that enter the market are thoroughly assessed for safety before they are approved. This means that all GM food and feed must go through a detailed risk assessment process to make sure they are safe for consumption.

In addition to this, there is also the Cultivation Directive 2001/18/EC, which gives individual EU member states the power to decide whether to allow or ban the cultivation of GMOs within their territories. Even if a GMO product is approved for cultivation by the EU, a member state can still choose to restrict or prohibit its use in all or part of its territory. This flexibility allows countries within the EU to make decisions based on their specific concerns or preferences regarding GMOs.

Despite the EU’s cautious approach to GMOs, only two GM crops have been approved for cultivation in the last 25 years. Of these, only one, the MON810 insect-resistant maise, is currently being cultivated, primarily in Spain.

The EU defines GMOs in a way that focuses on the process by which they are created. For example, in 2018, the European Court of Justice ruled that organisms modified using techniques like CRISPR-Cas9 fall under the EU’s definition of a GMO. This means that even newer gene-editing technologies are subject to the same strict regulations as traditional GMOs.

The United States GM Regulations

In the United States, there isn’t a single federal law specifically for regulating genetically modified organisms (GMOs). Instead, GMO regulation is handled by several government agencies under a system known as the Coordinated Framework for Regulation of Biotechnology. This framework directs different types of GMO products to the appropriate regulatory bodies, where they are assessed using the same health, safety, and environmental laws that apply to conventional products.

Three main agencies are involved in the regulation of GMOs:

1. Food and Drug Administration (FDA): The FDA oversees the safety of GM foods and animal feed, ensuring that they are safe to eat and properly labeled.
2. Environmental Protection Agency (EPA): The EPA is responsible for regulating GM crops that are designed to be resistant to pests or that have been modified to produce pesticides. They assess the environmental impact of these crops.
3. United States Department of Agriculture (USDA): Within the USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for regulating the introduction of GM plants. APHIS determines whether a GM plant is “regulated” or “non-regulated.” If a plant is deemed “non-regulated,” it can be cultivated, imported, and transported without further oversight from APHIS.

Recently, APHIS has granted non-regulated status to GM plants that do not contain foreign DNA, including those modified using CRISPR-Cas9. This means that these plants can be grown and distributed without additional APHIS regulation.

In summary, the U.S. uses a coordinated approach involving multiple agencies to regulate GMOs, focusing on health, safety, and environmental impact rather than creating specific laws for GMOs.

Canada GM Regulations

Canada takes a product-oriented approach in the regulation of genetically modified organisms (GMOs). This means Canada focuses on the end product itself, rather than the method of making it. If a plant has a novel trait—a new or different trait not found in normal plants—it must pass through a thorough risk assessment, whether it was developed through traditional breeding, mutagenesis, or through advanced technology such as CRISPR. -Cas9. 

Canada’s risk assessment system is strictly science-based and evaluates factors such as a product’s allergenic potential (whether it can cause allergic reactions), toxicity, and any adverse effects on the environment or other organisms. 

For example, in 2013, the Canadian government tested Falco Canola TM , a weed-tolerant canola developed using new editing technologies such as CRISPR-Cas9. After testing, they concluded it was no different from traditional canola varieties and declared it a non-GM crop. This reflects Canada’s focus on the characteristics of the final product rather than the process of making it. 

In short, Canada’s genetic modification regulations are based on product characterisation and extensive scientific testing to ensure safety and consistency, regardless of how the product is developed.

Gene Modification Regulations In Africa

Gene modification regulations in Africa are gradually taking shape as the continent navigates the complexities of adopting genetically modified crops. Currently, only three countries—South Africa, Burkina Faso, and Sudan—have embraced GM crops on a commercial scale. These nations primarily focus on traits like herbicide tolerance and insect resistance, which offer significant agricultural benefits.

Beyond these commercial ventures, eleven other African countries are engaged in confined field trials of GM crops. These trials allow for controlled experimentation with genetically modified varieties, helping to assess their potential before broader adoption. However, the growing adoption of GM crops has led to concerns about cross-border movement, especially in regions where countries share borders with GM crop-producing nations. Unauthorised cultivation has already been observed, such as along the Ethiopia-Sudan border, where farmers are growing GM cotton strains without regulatory approval.

To address these challenges, Africa must develop robust, practical, and flexible gene modification regulations. Effective regulatory frameworks are essential to prevent the unregulated spread of GM crops while allowing the continent to leverage the benefits of GM technology for agricultural productivity. Furthermore, harmonizing GMO policies across regional blocs is crucial. As informal seed exchanges often occur across borders, consistent regulation is necessary to manage these movements and ensure safe and responsible GMO adoption.

As Africa strives to enhance agricultural productivity to achieve food security, GM crops could play a vital role. With the right regulatory support, these technologies could contribute significantly to sustainable development, helping the continent meet its growing food needs.

Potential Benefits and Risks of GM Technology

There are several benefits and challenges associated with genetically modified Agri-products. They include: 

Benefits of Genetically Modified Agri-Products 

• Attractiveness to Consumers: GMOs can produce foods that are less likely to bruise or brown, making them more appealing to consumers.
• Resilience and Less Waste: GMO crops are more resistant to herbicides, plant viruses, insects, and harsh climates, which reduces food loss and waste.
• Nutritional Value: Some GMOs, like golden rice, are engineered to enhance nutritional content, providing more essential nutrients, especially in areas with deficiencies.
• Higher Yields: GMO crops often produce higher yields, helping farmers grow more food, which can lower costs and improve food security.

Challenges of Genetically Modified Agri-Products 

• Allergic Reactions: There’s a small risk that GMOs could trigger allergies if they involve genes from allergenic sources.
• Cancer Concerns: Although there’s no evidence linking GMOs to cancer, some concerns exist, and long-term effects are still unclear.
• Antibiotic Resistance: GMOs with antibiotic-resistant genes could theoretically transfer this resistance to humans or animals, but the risk is considered very low.
• Changes in Human DNA: While some fear GMOs could alter human DNA, research shows that food DNA generally breaks down before it could have any impact.
• Toxicity Concerns: Older studies suggested possible organ toxicity from GMOs, but no conclusive evidence has been found, and GMOs may actually reduce toxicity by lowering pesticide use.
• Environmental Impact: Potential environmental risks include gene transfer to wild plants, negative effects on insects and species, and reduced biodiversity.

Conclusion

In summary, the global regulatory environment for genetically modified organisms (GMOs) is complex and varies widely from region to region. While some countries, such as the United States and Canada, are more product-oriented, others, such as the European Union, are more process-oriented closely regulating the methods used to create GMOs.

Africa, meanwhile, is gradually developing a legal framework to balance the potential benefits of genetic modification technologies with the need for biosecurity and integrated policies. Although the methods are different, the overall goal is the same: to ensure that the agricultural products produced are safe for humans, animal health and the environment. 

Through strong laws, based on science and continuous research, it is possible to increase the productivity of genetically modified agri-products designed to help meet the nutritional needs of the world’s population.