The US Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs referred to as GalSafe pigs. These pigs may be used for food and human therapeutics. This will be the first time that the regulator has approved an animal biotechnology product for both food and biomedical purposes.
Intentional genomic alteration in animals means making specific changes to the genome of the organism using modern molecular technologies that are popularly referred to as “genome editing” or “genetic engineering”. However, there are other technologies that can be used to make IGAs in animals.
Such changes in the DNA sequence of an animal may be carried out for following reasons
- Research purposes, to produce healthier meat for human consumption.
- To study disease resistance in animals among other reasons.
- Making an animal more susceptible to certain diseases such as cancer, which helps researchers get a better understanding of the disease and develop new therapies to treat it.
The FDA maintains that the only difference between an animal with an IGA and one that does not have an IGA is that the IGA gives them a new trait or characteristic, such as faster growth or resistance to certain diseases. Essentially, an IGA is inserted into an animal to change or alter its structure and function and the FDA makes sure that the IGA contained in the animal is safe for the animal and safe for anyone who consumes a product or food derived from the animal.
The FDA made the announcement and allowed IGA in GalSafe pigs to eliminate a type of sugar found in mammals called alpha-gal. This sugar is present on the surface of these pigs’ cells and when they are used for products such as medicines or food (the sugar is found in red meats such as beef, pork and lamb), the sugar makes some people with Alpha-gal Syndrome (AGS) more susceptible to developing mild to severe allergic reactions.
Since GalSafe pigs may potentially be used to produce human medical products, IGA will help eventually free these products from detectable alpha-gal sugar, thereby protecting their human consumers from potential allergies. According to the FDA, GalSafe pigs may also be used to make the blood-thinning drug heparin.
In India, Genetically Modified Organisms (GMOs) and the products thereof are regulated under the Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989 (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. The Rules, 1989 are supported by a series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc. These rules are very broad in scope essentially covering the entire spectrum of activities involving GMOs and products thereof.
India has taken steps in the direction of genetic modification through initiatives like – Indian GMO Research Information System which is a database on activities involving the use of GMOs and products thereof in India. The primary purpose of this website is to make available objective and realistic scientific information relating to GMOs and products thereof under research and commercial use to all stakeholders including scientists, regulators, industry and the public in general. It is also expected to promote collaborations and avoid duplication of work.
