THE LEGAL AND ETHICAL ASPECTS OF GENETIC ENGINEERING AND BIOTECHNOLOGY Vamsi Priya Legal Article Sat, Jun 24, 2023, at ,12:09 PM ABSRACTIn the Indian scenario, there has been much acceptance of genetically modified crops. Which is why Bt cotton is the only GM crop in the market. This paper looks into the various legal and ethical aspects of genetic engineering and biotechnology.KEYWORDS: genetic engineering, ethical, legal, biotechnology, India, humansINTRODUCTIONThe scientific study of recombinant DNA--- known colloquially as “genetic engineering---- has shown a singular talent for attracting public approbation as well as exciting public fears. Why this should be so difficult to say, though several factors probably make significant contributions. First, genetic engineering deals with nothing less than the elementary language of life, the letters and words by which cells translate their genetic code, inherited from their predecessors, into the daily biochemical business of life. Genetic engineering allows us to peek at the letters themselves, which we know well.For example, commercial production of human insulin involved isolating, spelling out, and copying the human gene that produces insulin and then inserting it into a microorganism. Finally, that microorganism had to be taught to “speak” insulin--- to express the gene product.All this has been accomplished, and human sufferers from diabetes may no longer have to rely on animal insulin, which is slightly different from human insulin although biologically active in humans.Biotechnology began at least 6,000 years ago with the agricultural revolution. This early era was characterized by exploiting living organisms in their natural forms or modifying their genetic makeup through selective breeding.Around the same time, humans learned to harness the biological process of fermentation to produce bread, alcohol and cheese. People also began changing the genetic makeup of domesticated plants and animals through selective breeding.Selective breeding works by breeding parents with desirable characteristics to express or eliminate certain genetic characteristics in their offspring. Over time, species that are selectively bred evolve to be different from their wild ancestors. For instance, during the agricultural revolution, wheat was selectively bred to stay on its stem when harvested instead of falling to the ground like wild wheat. Dogs were selectively bred to be more docile than their wolf ancestors.Like all countries, India faces the reality that modern biotechnology is unlocking many advances in healthcare, food and energy security, and environmental conservation. At the same time, these same breakthroughs are ushering in a host of potential threats, including biological warfare and irreversible alterations to the human gene pool.THE ETHICAL ISSUES OF BIOTECHNOLOGY AND GENETIC ENGINEERINGDespite all this promise, however, some aspects of biotechnology are raising profound ethical and political dilemmas that must be addressed, particularly related to the alteration of genetic material. The most important concern is unintended, potentially harmful genetic mutations. For instance, the possible medical applications of CRISPR pose a fresh round of ethical and legal quandaries for the world. While this technology is intended to treat debilitating hereditary diseases, it can interfere with cellular signaling pathways or be used to edit genes on the human germ line. Changes to the latter would be passed down to subsequent generations, permanently altering the human gene pool with potentially dangerous consequences. Another point of contention is intentional gene drives, that is to say, efforts to genetically enhance specific traits and their chances of being inherited by future generations, which could lead to a loss of human genetic diversity. Furthermore, while big data applications in the fields of genomics and bioinformatics have immense potential, such innovations also raise fundamental questions about data privacy, particularly regarding how to protect individuals’ genetic information and how to govern the commercial use of such private genetic data.The use of biotechnology has raised a number of ethical, legal, and social issues. Here are just a few: Who owns genetically modified organisms such as bacteria? Can such organisms be patented like inventions? Are genetically modified foods safe to eat? Might they have unknown harmful effects on the people who consume them? Are genetically engineered crops safe for the environment? Might they harm other organisms or even entire ecosystems? Who controls a person’s genetic information? What safeguards ensure that the information is kept private? How far should we go to ensure that children are free of mutations? Should a pregnancy be ended if the fetus has a mutation for a serious genetic disorder? LEGAL AND REGULATORY ISSUES IN BIOTECHNOLOGYThere are around three issues which are legal and regulatory under Biotechnology. These issues are as follows: –Managing the opportunities and challengesThe recent developments in the field of biotech in India and around the world has given immense gains in the field of agriculture, food, pharmaceuticals etc. It has created an opportunity for markets selling biotechnological products in order to cater the needs of the huge population. Also, biotech is facing challenges in developing new products by using sceptical technologies. Many companies are fully dependent on manufacture, packaging and proper transportation of the materials. India’s biotechnology industry is really very small compared to the pharmaceutical industry. Most of the biotech industries carry out activities which are only focused on agriculture and pharma. Many industries are also collaborating with other industries in order to have a proper R&D and also diversify their business. This had led to opening of wider opportunities in this field.Overview of issues for discussionTalking about the issues, the biotech industry has certain ethical issues which is really very harmful for the industries to survive. Talking on the basis of agriculture, GM crops are the source of food for people. Many times, those crops are not labelled properly because agencies think that the food products are based on similarity to existing foods, its chemical composition and effect on the digestive system of animals. If a food is found to contain a chemical which causes allergies, is not at all labelled. Regional and country reportsTalking about reports on biotech based on regions and countries, the highest number of industries are located in the USA i.e. 5700 companies or 24.39% and the countries which have the lowest companies are Italy, Sweden, South Korea, Mexico, India and the Netherlands which represent 5.6% or 3.2% shares. These states determine that the biotech industries are developed a lot in the developed countries like Western Europe and Brazil. While there are some countries which are under the initial stages of development like China or Brazil.REGUALTIONS OF GMO’S IN INDIAIn India, Ministry of Environment, Forest and Climate Change (MoEFCC) introduced the Environment (Protection) Act, 1986 as umbrella legislation to provide a holistic framework for the protection and improvement of the environment. Thereafter, a series of Rules were notified to deal with varied issues such as hazardous chemicals, hazardous wastes, solid wastes, biomedical wastes, etc. Rules, 1989 are implemented by MoEFCC together with the Department of Biotechnology (DBT), Ministry of Science & Technology, and state governments.In reference to the utilization of micro-organisms and application of gene technology, the MoEFCC notified the “Rules for manufacture, use/import/export & storage of hazardous microorganisms/genetically engineered organisms or cells, 1989” as per powers conferred by Sections “Regulation of Genome Engineering Technologies in India”, Section 8 and 25 of Environment (Protection) Act, 1986.Six Competent Authorities and their composition have been notified under these Rules that include: rDNA Advisory Committee (RDAC) Institutional Bio-safety Committee (IBSC) Review Committee on Genetic Manipulation (RCGM) Genetic Engineering Appraisal Committee (GEAC) State Biotechnology Coordination Committee (SBCC) District Level Committee (DLC) RELEVANT ACTS AND RULES REGULATING GMOs IN INDIA Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Micro-organisms/ Genetically Engineered Organisms or Cells, 1989 issued under EPA: Cover entire spectrum of activities involving GMOs and products thereof including the sale, storage, exportation, importation, production, manufacturing, packaging, etc. Foodstuffs have been moved out of the purview of Rules, 1989 recently. Plant Quarantine (Regulation For Import Into India) Order 2003: Covers regulation of import of germplasm / GMOs/transgenic plant material for research purpose. Biological Diversity Act, 2002– Regulates the use of biological resources including genes used for improving crops and livestock through genetic intervention. The Food Safety and Standards Act, 2006– Regulates manufacture, storage, distribution, sale, and import of food which includes GM food.CONCLUSIONLaw relating to biotechnology is a growing field of law, which in precision puts together different disciplines of law such as IPR Law, Trade Law, Environmental Law, Biodiversity Law, Human Rights Law and such other connected laws together. It also includes various international, multinational, regional and national level legal instruments and initiatives on the subject of governance of biotechnology together in one go.