Genetically Modified Organism (GMO) | 13 Sep 2023

What is Genetically Modified Organism (GMO)?

• About:
  • A genetically modified organism (GMO) refers to an entity, whether it's an animal, plant, or microorganism, that has undergone modifications to its DNA using genetic engineering methods.
  • Across generations, specific traits have been cultivated in crops like corn, animals like cattle, and even domestic companions like dogs through selective breeding. Yet, in recent decades, the progress of biotechnology has enabled researchers to directly manipulate the genetic makeup of microorganisms, plants, and animals.
• Genetic Modification:
  • It involves altering the DNA of an organism to introduce specific traits or characteristics. There are several techniques used in genetic modification, each with its own advantages and applications.

What is the Genetic Engineering Appraisal Committee (GEAC)?

• The Genetic Engineering Appraisal Committee (GEAC) functions in the Ministry of Environment, Forest and Climate Change (MoEF&CC).
• It is responsible for appraisal of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle.
• The committee is also responsible for appraisal of proposals relating to release of genetically engineered (GE) organisms and products into the environment including experimental field trials.
• GEAC is chaired by the Special Secretary/Additional Secretary of MoEF&CC and co-chaired by a representative from the Department of Biotechnology (DBT). Presently, it has 24 members and meets every month to review the applications in the areas indicated above.

What are the Important Gene Editing Techniques?

• Recombinant DNA Technology: This technique involves isolating and cutting specific DNA segments from one organism (source) and inserting them into the DNA of another organism (host). The host organism then incorporates the new DNA into its genome, expressing the desired trait. This technique is widely used in producing genetically modified crops and pharmaceuticals.
• CRISPR-Cas9: The CRISPR-Cas9 system is a revolutionary gene editing tool that allows scientists to precisely target and modify specific DNA sequences. It can be used to add, delete, or replace genes in a wide range of organisms, from bacteria to plants and animals.
• TALENs (Transcription Activator-Like Effector Nucleases): TALENs are another gene editing technique that can be programmed to target specific DNA sequences. They work similarly to CRISPR-Cas9 and have been used for genetic modification in various organisms.
• RNA Interference (RNAi): RNA interference (RNAi) is a natural cellular process that plays a crucial role in regulating gene expression within eukaryotic cells. This triggers the degradation of the target gene's messenger RNA (mRNA), resulting in reduced expression of the corresponding protein.
• Somatic Cell Nuclear Transfer (Cloning): This technique involves transferring the nucleus of a somatic cell (any cell except sperm or egg cells) into an egg cell from which the nucleus has been removed. This process creates a genetically identical organism (clone). Dolly the sheep was famously created using somatic cell nuclear transfer.
• Synthetic Biology: Synthetic biology involves designing and constructing new biological parts, devices, and systems, as well as redesigning existing biological systems. It often includes the synthesis of DNA sequences, modifying existing genes, and constructing novel genetic circuits.
• Viral Vectors: It is modified viruses that can carry specific genes into target cells. They are used in gene therapy to deliver therapeutic genes to treat genetic disorders.
• Selectable Markers and Reporter Genes: These are genes introduced alongside the desired gene to assist in the identification and selection of genetically modified organisms. Selectable markers confer resistance to specific antibiotics or chemicals, while reporter genes produce easily detectable proteins (e.g., fluorescent proteins) to indicate successful gene transfer.
• Agrobacterium-Mediated Transformation: This method uses the natural ability of the bacterium Agrobacterium tumefaciens to transfer genetic material into plants. The bacterium is engineered to carry the desired gene, and when it infects the plant, the gene is integrated into the plant's genome.
• Microinjection: This technique involves using a fine needle to inject foreign DNA directly into the nucleus of a target cell. It is often used in animal genetic modification.
• Electroporation: Cells are exposed to an electric field, which temporarily disrupts the cell membrane, allowing foreign DNA to enter.

What are the Advantages of Gene Editing ?

• Precision in Genetic Modification: Gene editing allows for highly precise changes to be made to an organism's DNA. This precision can target specific genes or genetic sequences with accuracy.
• Agricultural Advancements: Gene editing can be applied to crops and livestock to enhance their characteristics, such as increased yield, disease resistance, or nutritional content, potentially addressing food security and sustainability challenges.
• Agricultural Advancements: It can be applied to crops and livestock to enhance their characteristics, such as increased yield, disease resistance, or nutritional content, potentially addressing food security and sustainability challenges.
• Reduced Use of Chemicals: In agriculture, genetically modified crops created through gene editing could require fewer pesticides and herbicides, benefiting both the environment and human health.

What are Genetically Modified (GM) Plants?

• GM plants are plants that have undergone intentional alteration of their genetic material through genetic engineering techniques. These modifications are carried out to introduce specific traits or characteristics that may not naturally occur within the plant's genome. For example:
  • Bt Cotton: Bacillus Thuringiensis (Bt) cotton is engineered to produce a protein from the bacterium Bacillus Thuringiensis that is toxic to certain insect pests. The bacteria release specialized proteins referred to as "cry proteins," which exhibit toxicity towards insects.This trait reduces the need for chemical insecticides and helps protect the cotton crop from damage.
  • Golden Rice: Golden rice is modified to produce higher levels of beta-carotene, a precursor of vitamin A. This modification aims to address vitamin A deficiency, a major public health concern in many developing countries.
  • Drought-Resistant Crops: Some plants have been engineered to tolerate drought conditions better by introducing genes that help the plant conserve water or withstand dehydration stress.
  • Insect-Resistant Eggplant (Bt Brinjal): Similar to Bt cotton, Bt brinjal (eggplant) produces a protein toxic to certain insect pests. This modification reduces the need for chemical insecticides, benefiting both farmers and the environment.
  • Papaya Ringspot Virus-Resistant Papaya: Hawaiian papaya crops were genetically modified to resist the papaya ringspot virus, which had previously devastated papaya production in Hawaii.
  • Flavr Savr Tomato: The Flavr Savr tomato was one of the first genetically modified foods. It was engineered to have a longer shelf life by suppressing the gene responsible for softening and decay.
  • Resistant Cassava: Cassava, a staple crop in many parts of the world, has been modified to resist viral diseases that can significantly reduce yields.
  • Frost-Tolerant Strawberries: Strawberries have been genetically modified to tolerate frost, allowing for extended growing seasons in colder climates.
  • Non-Browning Apples: Apples have been engineered to resist browning when sliced or bruised, which can help reduce food waste and increase their shelf life.

What are Genetically Modified Medicines?

• GM medicines, also known as biopharmaceuticals or biologic drugs, are pharmaceutical products produced using genetic engineering techniques. These drugs are derived from living organisms, such as bacteria, yeast, or mammalian cells, that have been genetically modified to produce therapeutic proteins or other bioactive molecules.
  • Insulin: Recombinant DNA technology has been used to produce insulin for the treatment of diabetes. Human insulin genes are inserted into bacterial or yeast cells, which then produce insulin that is identical to the naturally occurring hormone.
  • Human Growth Hormone (HGH): Genetically modified bacteria or mammalian cells are used to produce synthetic human growth hormone, which is used to treat growth disorders in children and hormone deficiencies in adults.
  • Erythropoietin (EPO): EPO, a hormone that stimulates the production of Red Blood Cells (RBC), is produced using genetically modified mammalian cells. It is used to treat anemia associated with conditions such as kidney disease and chemotherapy.
  • Monoclonal Antibodies: These are a class of genetically engineered proteins used to treat various diseases, including cancer, autoimmune disorders, and inflammatory conditions. Monoclonal antibodies are produced by modifying mammalian cells to produce specific antibodies that target disease-related molecules.
  • Blood Clotting Factors: Genetically modified cells are used to produce blood clotting factors, such as Factor VIII and Factor IX, for the treatment of hemophilia.
  • Vaccines: Some vaccines are produced using genetically modified organisms, such as yeast or bacteria, to express antigens that stimulate an immune response. For example, the hepatitis B vaccine is produced using genetically modified yeast cells.
  • Enzyme Replacement Therapies: Genetic engineering is used to produce enzymes that are deficient or absent in certain genetic disorders. For instance, enzyme replacement therapies are used to treat conditions like Gaucher's disease and Fabry disease.
  • Cancer Therapies: Genetically modified T cells (a type of immune cell) are being developed as a form of immunotherapy for certain types of cancer. These modified T cells are engineered to express Chimeric Antigen Receptors (CARs) that target cancer cells.
  • Clot-Dissolving Agents: Genetically modified bacteria or yeast can be used to produce clot-dissolving enzymes, such as tissue plasminogen activator (tPA), which is used in the treatment of certain types of strokes and heart attacks.

What are Genetically Modified Animals?

• Genetically modified (GM) animals are those that have been deliberately modified through genetic engineering methods, aiming to incorporate particular traits or features that might not exist naturally in the animal's genetic makeup.
  • GloFish: GloFish are genetically modified zebrafish that have been engineered to express fluorescent proteins from jellyfish and coral. These fish are used in scientific research and as pets to study genetic traits and environmental pollutants.
  • AquAdvantage Salmon: These salmon have been genetically modified to grow faster and reach market size more quickly. They contain genes from Chinook salmon and ocean pout, allowing them to produce growth hormone year-round.
  • Enviropig: Enviropigs have been genetically modified to produce less phosphorus in their waste, potentially reducing the environmental impact of pig farming on water quality.
  • Knockout Mice: Mice are often genetically modified to have specific genes "knocked out" or deactivated. This allows researchers to study the effects of gene function and develop models for human diseases.
  • Transgenic Goats: Goats have been engineered to produce certain proteins in their milk that can be extracted and used for pharmaceutical purposes. For example, transgenic goats can produce antithrombin, a protein used in blood clotting disorders.
  • Genetically Modified Mosquitoes: Mosquitoes have been genetically modified to reduce their ability to transmit diseases like malaria and dengue fever. Modified mosquitoes can be engineered to carry a gene that prevents the development of the disease-causing parasite.
  • Dolly the Sheep: Dolly was the first mammal cloned from an adult somatic cell using a technique called somatic cell nuclear transfer. While not a traditional genetic modification, cloning involves altering the genetic makeup of an organism through a different process.
  • Genetically Modified Pigs for Organ Transplants: Pigs have been modified to express human genes in their organs, with the goal of making their organs suitable for transplantation into humans (xenotransplantation).
  • Featherless Chickens: Some genetically modified chickens have been bred to have fewer feathers, which could reduce the need for plucking during processing.
  • Spider Silk-Producing Goats: Certain goats have been genetically modified to produce spider silk proteins in their milk. These proteins can be used to create strong and lightweight materials.

What is the status of Genetically Modified Organisms in India?

• Bt Cotton:
  • Indian farmers started cultivating Bt cotton, a pest-resistant, genetically modified version of cotton, in 2002-03.
  • Bt modification is a type of genetic modification where the Bt gene is obtained from the soil bacterium Bacillus Thuringiensis.
  • It has been genetically modified (GM) to produce an insecticide to combat the cotton bollworm, a common pest.
  • Bt cotton is resistant to bollworm, a pest that destroys cotton plants.
  • By 2014, around 96% of the area under cotton cultivation in India was Bt cotton.
  • It makes India the fourth-largest cultivator of GM crops by acreage and the second largest producer of cotton.
  • Bt cotton is the only transgenic crop that has been approved by the Centre for commercial cultivation in India.
• GM mustard:
  • GEAC recently approved commercial cultivation of genetically modified mustard.
  • Dhara Mustard Hybrid (DMH -11) was developed by a team of scientists at Delhi University.
  • It uses a system of genes from soil bacterium that makes mustard generally a self-pollinating plant better suited to hybridisation than current methods.
  • In September 2017, a feasibility report said that the developers of DMH-11 claimed a yield increase of 25-30% over non-hybrids, which was refuted by several NGOs.
  • The GEAC cleared “the environmental release of mustard hybrid DMH-11 for its seed production and testing as per existing ICAR guidelines and other extant rules/regulations prior to commercial release.
• Bt Brinjal:
  • The GEAC in 2007, recommended the commercial release of Bt Brinjal.
  • It was developed by Maharashtra Hybrid Seeds Company in collaboration with the University of Agricultural Sciences, Dharwad and the Tamil Nadu Agricultural University.
  • India has banned the cultivation of Bt brinjal in 2010.
  • This initiative was blocked in 2010.

What is the Regulatory Framework in India?

• Institutions:
  • All the activities,operations and products related to the genetically modified organisms are regulated by the Ministry of Environment, Forest and Climate.
  • It is regulated under the Environment (Protection) Act, 1986.
  • Genetic Engineering Appraisal Committee (GEAC) under MoEFCC is authorized to review, monitor and approve all activities of GMO.
  • These activities include import, export, transport, manufacture, use or sale of GMO.
  • GM foods are also subjected to regulations of Food Safety and Standards Authority of India (FSSAI).
• Acts and rules:
  • Environment Protection Act, 1986 (EPA)
    • The Genetic Engineering Appraisal Committee (GEAC) serves as the principal regulatory authority for biotechnology in India. Operating as a statutory body, it operates under the purview of the Ministry of Environment, Forests and Climate Change (MoEFCC) and is established in accordance with the Environment Protection Act, 1986.
  • Biological Diversity Act, 2002
    • Under the Act, any organization or individual seeking to access Indian biological resources, including those for GMO research or commercialization, is required to obtain prior approval and enter into benefit-sharing agreements with the National Biodiversity Authority (NBA).
    • The Act aims to ensure that the benefits arising from the utilization of these resources are shared fairly with local communities and indigenous people.
  • Plant Quarantine Order, 2003
    • The Plant Quarantine Order, 2003, includes provisions for regulating the import and export of GMOs, including genetically modified (GM) plants and plant materials.
  • Food Safety and Standards Act, 2006
    • The Food Safety and Standards Act, 2006, empowers the Food Safety and Standards Authority of India (FSSAI) to establish safety standards for food products, including those derived from GMOs. It includes provisions for conducting safety assessments to determine the suitability of GMO-derived foods for human consumption.

What are the Conventions Related to Genetically Modified Organisms?

• Convention on Biological Diversity (CBD):
  • It is a legally binding treaty to conserve biodiversity.
  • Objectives:
    • The conservation of biological diversity.
    • The sustainable use of the components of biological diversity.
    • The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.
  • Secretariat: Montreal, Canada.
    • It operates under the United Nations Environment Programme.
• The Cartagena Protocol on Biosafety:
  • It primarily deals with the transboundary movement of living modified organisms (LMOs), it includes provisions related to the handling, transport, and use of GMOs, which can include GMOs in animals.
  • The Cartagena Protocol on Biosafety, a supplement to the Convention on Biological Diversity.
  • It was approved in 2000.
  • It came into force in 2003.
• Nagoya Protocol:
  • Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization Genetically Modified Organisms (GMO).
  • It was adopted in 2010 in Nagoya, Japan at COP10.
  • Nagoya Protocol entered into force in 2014.

What are the Concerns Associated with the GMO?

• Environmental Impact: One of the major concerns is the potential for GMOs to have unintended and irreversible effects on the environment. There is a fear that genetically modified crops could crossbreed with wild relatives, potentially creating invasive species or altering natural ecosystems.
• Biodiversity: The introduction of GMOs can impact biodiversity by potentially reducing the diversity of plant and animal species. This could happen if GMOs outcompete Non-GMO species or if the use of GMOs leads to a reduction in traditional, locally adapted crop varieties.
• Unintended Consequences: Genetic modifications may have unintended consequences that are difficult to predict, such as producing allergens or toxins that were not initially identified during testing.
• Health Concerns: Some people are concerned about the potential effects of consuming GMOs on human health. While GMOs currently on the market have undergone rigorous safety assessments, some worry that long-term health effects may not be fully understood.
• Corporate Control and Monopoly: A significant ethical concern is the concentration of power and control over the food supply in the hands of a few large corporations. The patenting of GMOs allows companies to have exclusive rights to these genetic modifications, potentially limiting access to seeds and forcing farmers into dependency on a few suppliers.
• Labeling and Consumer Choice: Many people believe that they have a right to know whether the products they consume contain GMOs. The lack of mandatory labeling in some regions has led to concerns about transparency and the ability of consumers to make informed choices.
• Social and Economic Impacts: The adoption of GMOs can have complex social and economic implications, particularly in developing countries. While GMOs have the potential to increase crop yields and improve food security, concerns exist about the impact on small-scale farmers and traditional farming practices.
• Ethical Treatment of Animals: Genetic modification is not limited to crops; it also involves modifying animals for various purposes, such as enhancing livestock productivity. Ethical concerns arise about the welfare and treatment of these genetically modified animals.
• Cross-Contamination: The inadvertent mixing of GMOs with non-GMO crops is a concern, as it can lead to unintended GMO presence in organic or non-GMO crops, which can affect markets that demand GMO-free products.
• Long-Term Effects: Predicting the long-term effects of GMOs on ecosystems, human health, and society is challenging. The rapid pace of genetic engineering may outpace our understanding of potential risks.

Way Forward:

• Comprehensive Risk Assessment: Continue to conduct rigorous and transparent risk assessments of GMOs before they are released into the environment or the market. This includes evaluating potential environmental impacts, human health risks, and unintended consequences.
• Transparency and Labeling: Implement clear and mandatory labeling of GMO products to allow consumers to make informed choices. This promotes transparency and respects consumer rights to know what they are purchasing and consuming.
• Research and Development: Invest in further research to better understand the long-term effects of GMOs on the environment, biodiversity, human health, and social systems. Collaborative efforts involving scientists, regulators, and stakeholders can help ensure that risks are adequately addressed.
• Bioethics and Public Engagement: Involve a diverse range of stakeholders, including scientists, ethicists, farmers, consumers, and NGOs, in discussions about the development and deployment of GMOs. This participatory approach can help ensure that various perspectives are considered and ethical concerns are adequately addressed.
• Environmental Monitoring: Establish ongoing monitoring systems to track the environmental and health impacts of GMOs once they are released. This would allow for timely detection and management of any unexpected issues.
• Sustainable Agriculture: Focus on developing GMOs that contribute to sustainable agricultural practices, such as crops with increased drought or pest resistance, reduced need for chemical inputs, and improved nutritional content.
• Biodiversity Protection: Design GMOs in a way that minimizes their potential to negatively impact biodiversity. This could involve implementing containment measures, selecting traits that have a low risk of causing harm, and using gene editing techniques that have fewer off-target effects.
• International Collaboration: Establish international agreements and guidelines for the development, testing, and trade of GMOs. This would ensure consistent standards and regulatory approaches across countries and facilitate the responsible use of GMOs globally.