Priyanshi Gupta
2nd year Law Student at Dharmashatsra National Law University, Jabalpur
"The absence of regulations on the commercial production or marketing of cloned animals can have several significant consequences across ethical, economic, and societal dimensions"
What is gene editing?
The capacity to precisely alter a living organism's DNA sequence, or "customize" its genetic composition, is known as gene editing. Enzymes, specifically nucleases that have been designed to target a specific DNA sequence, are used in gene editing to create cuts in the DNA strands that allow replacement DNA to be inserted in place of the original DNA.[1]
What are the applications of gene editing?
Gene editing's applications in plants and animals are extensive and transformative, benefiting agriculture, conservation, and biomedical research. In agriculture, gene editing allows precise modifications to enhance crop traits such as yield, nutritional content, and resistance to pests and diseases.[2]This technology is pivotal in developing crops resilient to environmental stresses like drought and heat, thereby bolstering food security and reducing reliance on chemical inputs.
In animals, gene editing plays a crucial role in improving livestock health by developing disease-resistant animals and enhancing productivity. Biomedical research benefits from gene editing through the creation of animal models that mimic human diseases, facilitating the study of disease mechanisms and therapeutic development.[3] Furthermore, gene editing supports conservation efforts by enhancing genetic diversity in endangered species and improving their adaptability to changing environments. In livestock production, gene editing contributes to improving animal growth rates, reproductive efficiency, and the nutritional quality of animal products, thereby promoting sustainable agricultural practices.
Overall, gene editing technologies hold promise for addressing global challenges in agriculture, conservation, and medicine, ushering in a new era of precision and sustainability in both plant and animal systems.
How does gene editing work?
Several approaches to genome editing have been developed. Gene editing encompasses several powerful techniques that enable precise modifications to an organism's DNA. Among the most prominent methods is CRISPR-Cas9, which uses the Cas9 enzyme to cleave DNA at specific locations, allowing for the insertion, deletion, or alteration of DNA sequences with high efficiency and accuracy. TALENs (Transcription Activator-Like Effector Nucleases) and ZFNs (Zinc Finger Nucleases) are also utilized for gene editing, employing engineered proteins to target and cut specific DNA sequences. These methods have been instrumental in both basic research and applications such as gene therapy.
Recent advancements include prime editing, which combines Cas9 with a reverse transcriptase to directly rewrite DNA sequences without causing double-strand breaks, thus offering enhanced precision. Additionally, CRISPR systems like Cas12 and Cas13 have expanded the gene editing toolkit by targeting DNA and RNA respectively, enabling diverse applications including diagnostics and gene regulation. Alongside these editing techniques, Homology-Directed Repair (HDR) provides a pathway for cells to repair DNA breaks induced by gene editing tools, facilitating precise modifications by supplying a template DNA sequence. Each of these methods has revolutionized genetic research, offering unprecedented opportunities to study gene function, develop new therapies, and potentially address genetic diseases in animals.
What are the ethical implications of gene editing?
There are many different ethical factors to take into account when editing genes in plants and animals, and there may be unintended effects when changing an organism's natural state. Such modifications can, after all, affect the organism's development rate, metabolism, and/or reaction to outside environmental stimuli. These effects affect not just the genetically modified organism (GMO) but also the natural habitat in which it is permitted to flourish. Human health risks associated with genetically modified foods include the potential for additional allergy exposure and the spread of antibiotic-resistant genes to the gut flora.[4]
The Food and Agriculture Organization of the United Nations reports that, depending on the nation and the atmosphere in which the study was conducted, public acceptability trends in Europe and Asia are inconsistent. People's opinions on cloning, biotechnology, and genetically modified goods vary according to their educational background and their understanding of these concepts. Support varies according to the kind of biotechnology, but it is always lower when animals are brought up.
The idea that private firms may claim ownership of the organisms they generate and refuse to make them available to the public at a reasonable cost is another worry related to genetically modified organisms. Some people would still object to consumable genetically modified organisms (GMOs) despite extensive safety testing, notwithstanding equitable technology sharing. This resistance may stem from personal or religious convictions. Discussing the introduction of alien material into meals that are avoided for religious reasons, as well as our ability to "play God," are two ethical concerns concerning genetically modified organisms. There are those who maintain that manipulating nature is inherently immoral, while others contend that it is unethical to introduce plant DNA into animals or vice versa. Those who vehemently believe that the creation of genetically modified foods goes against nature or religion have demanded explicit labeling regulations for genetically modified goods so they can make educated decisions about what to buy.
Which law governs gene editing in India?
Because of advances in whole genome sequencing technology, gene cloning and transfer procedures, and our understanding of gene expression systems, there are more and more genetically modified organisms (GMOs) to take into account. Legislative procedures that govern this research must therefore adapt. Governments conduct risk assessments before approving the commercial use of genetically modified organisms (GMOs) to ascertain the potential outcomes of such usage. However, the problem of regulating these organisms stems from the challenges in determining the impact of commercial GMO use.[5]
In India, all activities related to Genetically Engineered organisms (GE organisms) or cells and
hazardous microorganisms and products thereof are regulated as per the "Manufacture,
Use/Import/Exportand Storage of Hazardous Microorganisms/ Genetically Engineered
Organisms or Cells, Rules, 1989" (Rules, 1989) notified by the Ministry of Environment, Forest
and Climate Change (MoEF&CC), Government of India under the Environment (Protection)
Act, 1986 (EPA 1986).
The guidelines highlight significant exemptions and regulatory changes concerning gene-editing technologies applied to plant genomes. Notably, researchers modifying plant genomes using gene-editing technology are now exempt from seeking approvals from the Genetic Engineering Appraisal Committee (GEAC), which typically evaluates genetically modified (GM) plants for release into farmer fields. This change signifies a shift in regulatory oversight, with the Environment Minister and state governments assuming final decision-making authority over the cultivation of such plants. The guidelines aim to provide a structured framework for the sustainable utilization of genome editing technologies, applicable to both public and private sector research institutions involved in research, development, and handling of genome-edited plants.
The guidelines address specific issues associated with GM plants, particularly those using transgenic technology, where genes from other species, such as the BT-cotton with a soil bacterium gene for pest resistance, are introduced. These GM plants have historically raised concerns due to the potential unintended spread of genes to neighboring plants, sparking controversies over their environmental and agricultural impacts. By exempting certain gene-edited plants from rigorous regulatory scrutiny, the guidelines seek to navigate these contentious issues while promoting innovation in agricultural biotechnology within controlled and sustainable parameters.
Current Indian legislation mandate that the GEAC evaluate all biotech food and agricultural goods, as well as products derived from biotech plants and animals, before they may be commercially approved or imported. The commercial production and marketing of cloned animals are unregulated.[6]
The absence of regulations on the commercial production or marketing of cloned animals can have several significant consequences across ethical, economic, and societal dimensions. Ethically, the lack of regulations raises concerns about animal welfare, as cloning procedures can involve health risks and welfare issues for the cloned animals themselves, such as higher rates of birth defects and health problems. Without proper regulations, there may be inadequate oversight to ensure that cloned animals are treated humanely throughout their lives.
From an economic standpoint, the unregulated production and marketing of cloned animals could impact markets and consumer confidence. The safety and quality of cloned animal products, such as meat and dairy from cloned livestock, might come into question without clear guidelines on their safety for consumption. This uncertainty could lead to market volatility and affect consumer acceptance and trust in these products. The unregulated cloning of animals could raise broader ethical and philosophical questions about the manipulation of genetic material and the implications for biodiversity.
Furthermore, without regulations, there may be inadequate measures in place to address environmental impacts, such as the potential unintended consequences of releasing cloned animals into natural ecosystems. Concerns about genetic diversity, disease susceptibility, and ecological balance could arise if cloned animals were introduced into wild populations without thorough evaluation and oversight.
Conclusion
In summary, the lack of regulations on the commercial production and marketing of cloned animals poses ethical, economic, and societal challenges that require careful consideration and governance to ensure responsible use of cloning technologies while addressing potential risks and impacts on animals, consumers, and the environment.
In conclusion, establishing comprehensive legislation is essential to address the ethical, economic, and societal complexities surrounding the commercial production and marketing of cloned animals. Such laws would provide a framework to ensure responsible use of cloning technologies while safeguarding animal welfare, consumer interests, and environmental integrity.
[1] BRITANNICA, https://www.britannica.com/science/gene-editing, (last visited Jun 30, 2024)
[2] NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE, https://www.nap.edu/catalog/23395/genetically-engineered-crops-experiences-and-prospects, (last visited Jun 30, 2024)
[3] U.S. NATIONAL LIBRARY OF MEDICINE, https://medlineplus.gov/genetics/understanding/genomicresearch/genomeediting/, (last visited Jun 30, 2024)
[4] MEDLINE PLUS, https://medlineplus.gov/genetics/understanding/genomicresearch/genomeediting/#:~:text=Genome%20editing%20(also%20called%20gene,genome%20editing%20have%20been%20developed, (last visited Jun 30, 2024)
[5] NATURE, https://www.nature.com/scitable/topicpage/genetically-modified-organisms-gmos-transgenic-crops-and-732/ , (last visited Jun 30, 2024)
[6] Global Gene Editing Regulation Tracker, https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/india-animals/#:~:text=Prior%20to%20commercial%20approval%20or,or%20marketing%20of%20cloned%20animal, (last visited Jun 30, 2024)
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