The US Food and Drug Administration (FDA) recently made headlines for its approval of an entirely new process – Intentional Genomic Alteration (IGA) – in a line of domestic pigs, referred to as GalSafe pigs. This represents the first instance of animal biotechnology product receiving the green light for both food and biomedical uses.
Understanding Intentional Genomic Alteration (IGA)
IGAs refer to the precise amendments made to the genome of an organism using modern molecular technologies, alternatively known as “genome editing” or “genetic engineering”. These technologies enable scientists to modify an organism’s DNA – the molecule responsible for carrying genetic instructions in all living beings.
Its structure resembles a double helix, and comprises two strands that wrap around each other, each having a backbone of alternating sugar (deoxyribose) and phosphate groups. With the help of genome editing technologies, genetic material can be added, removed, or altered at specific locations within the genome.
One such technology is Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR). It mirrors natural defence mechanisms in bacteria against viral invasions and uses a special protein called Cas9. For their contribution in developing CRISPR/Cas9 genetic scissors, Emmanuelle Charpentier of France and Jennifer A Doudna from the USA were awarded the 2020 Nobel Prize in Chemistry.
A Genetically Modified Organism (GMO) refers to any animal, plant, or microbe whose DNA has been modified using these genetic engineering techniques. IGAs are inserted into animals to alter their structure and function, conferring new traits. These could range from faster growth to resistance to certain diseases.
Applications of IGA
Changes in the DNA sequence of an animal could serve research purposes, enhance the quality of meat for human consumption, or contribute to the study of disease resistance in animals, among other benefits. IGAs can be used to make an animal more susceptible to conditions like cancer, providing researchers with a deeper understanding of the disease and aiding the development of new therapies.
FDA’s Stance on IGA
The FDA permitted IGAs in GalSafe pigs to eradicate alpha-gal, a type of sugar found in mammals. These genetically altered pigs could potentially be used to create human medical products devoid of detectable alpha-gal sugar, protecting potential human consumers from allergies. A prevalent allergen, alpha-gal sugar exists on the surface of GalSafe pigs’ cells, and its presence in red meats and medical products could cause mild to severe allergic reactions in individuals with Alpha-gal Syndrome (AGS).
Legislative Framework for GMOs in India
In India, GMOs and their derived products are regulated under the Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms, or cells, 1989, notified under the Environment (Protection) Act, 1986. Supported by a series of guidelines, these rules cover all activities involving GMOs and their products.
They are executed jointly by the Ministry of Environment, Forest and Climate Change (MoEFCC) and the Department of Biotechnology (DBT), Ministry of Science & Technology, along with state governments. Six competent authorities have been notified under these rules, including the rDNA Advisory Committee (RDAC), Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Appraisal Committee (GEAC), State Biotechnology Coordination committee (SBCC), and District Level Committee (DLC).
While RDAC is advisory, the IBSC, RCGM, and GEAC are regulatory and SBCC and DLC are for monitoring functions.
India’s GMO Research and Initiatives
To promote awareness and facilitate information sharing, the Indian GMO Research Information System was established. This database contains comprehensive data on the use of GMOs in India and aims to provide realistic scientific information to all stakeholders, including scientists, regulators, industry, and the public. Bt cotton, which uses alien genes from the soil bacterium Bacillus thuringiensis to develop a protein toxic to pink bollworm, is the only GM crop permitted in India.
In line with global standards, India is also a signatory of the Cartagena Protocol on Biosafety, designed to protect biological diversity from potential risks posed by Living Modified Organisms arising from modern biotechnology.
