The genetic engineering is one of the great marvels of 21st century human. It allowed for precise control over the genetic changes introduced into an organism. Today, we can incorporate new genes from one species into a completely unrelated species through genetic engineering, optimizing agricultural performance. India introduced Bt cotton seeds in 2002. It has greatly reduced the use of toxic pesticides. Bt cotton produces a common soil bacterium, Bacillus thuringiensis (Bt). It is a natural pest repelling bacteria that is toxic to many worms and pests that can harm the crop but is not hazardous to humans. Bt is widely sprayed on crops by organic farmers as a pesticide. As a result of the adoption of Bt cotton, India is now the largest cotton producer in the world. It reduces the use of pesticide and insecticide during farming that might be great moves for the betterment of the food supply. It can feed a rapidly increasing population because it shows dramatically increased yields. In India, GM plants like GM cotton, Bt brinjal and GM mustard are experimented, but the government refused to allow it to be commercialized¹.

KEYWORDS: Genetically modified foods, Genetically Engineered Foods, Biotechnology.

Biotechnology can be viewed as a group of useful, enabling technologies with wide and diverse applications in industry, commerce and the environment. Historically, biotechnology evolved as an artisanal skill rather than a science, exemplified in the manufacture of beers, wines, cheeses etc. where the techniques of manufacture were well understood but the molecular mechanisms went unknown. In more recent times, with the advances in the understanding of microbiology and biochemistry, all of these empirically derived processes have become better understood and as a result improved. The traditional biotechnology products have now been added to with antibiotics, vaccines, mono- clonal antibodies and many others, the production of which has been optimised by improved fermentation procedures and novel downstream processing It is clear that biotechnology has its roots in the distant past and has large, highly profitable, modern industrial outlets of great value to society. 2

Examples: the fermentation, biopharmaceuticals, and food industries.

Genetic Modification is a biological technique that effects alterations in the genetic

machinery of all kinds of living organisms. GMO is defined as follows by WHO (World Health Organization): “Organisms (i.e., plants, animals or microorganisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination”. The definition seeks to distinguish the direct manipulation of genetic material from the millennial-old practice of improvement in the genetic stock of plants and animals by selective breeding. With DNA recombinant technology, genes from one organism can be transferred into another, usually unrelated, organism 3.

The first-generation application of genetic engineering to crop agriculture has been targeted towards the generation of plants expressing foreign genes that confer resistance to virus, insects, herbicides or pest harvest deterioration and accumulation of useful modified storage product.

The classification of GM crops has been discussed below:

A)    International Regulation: There are five main elements of international regulation relating to research into, and the trade and use of GM crops:

The government regulates the seed industry and the seed trade in various respects. The Seed Act of 1966, the Seeds Control Order of 1983, and the Seeds Policy of 1988 are the major components of policy specific to the industry. The Seed Act of 1966 and the Seeds Control Order of 1983 provide statutory backing to the system of variety release, seed certification and seed testing. Varieties are released after evaluation at multi-location trials for a minimum of three years. Varieties approved are “notified” which is an obligatory for certification. While all public sector varieties go through this process, it is not compulsory for private varieties (Guidelines for Research in Transgenic Plants, 1998). Major changes in this system of regulation are proposed in the National Seeds Policy of 2002. Under this policy, variety registration (i.e., notification) is mandatory for all varieties, new and extant. The evaluation is done over three seasons of field trials. Besides regulating quality, the government has also controlled imports and exports of seed. The Seed Policy of 1988 allowed limited imports of commercial seed.

The emphasis on registration in the new seeds policy ties in with the demands of the Plant Variety Protection and Farmer’s Rights Act passed in 2001. This Act provides for plant breeder’s rights, which requires extant and new plant varieties to be registered on the basis of characteristics relating to novelty, distinctiveness, uniformity and stability.

The other major change in intellectual property protection has been the change in patent laws. The Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement came into force in WTO member countries in 1995. This requires member countries to comply with fixed minimum standards for intellectual property rights protection. As a result, India has amended its Patent Act in 1999, 2002 and 2005 5.

Several central ministries and departments are involved in India’s program of food quality and safety and hence each one of them has a role to play in the activities related to GM foods in India. These include:

The goal of the Indian regulatory system is to ensure that their genetically modified crops pose no major risk to food safety, environmental safety, agricultural production, and that there are no adverse economic impacts on farmers 6.

also allow the transfer of genes from one crop to another, creating “super weeds”, which will be immune to common control methods.

In March 2018, the Indian government had cut royalties that local seed companies pay to Monsanto, for the second times in two years. This was in the backdrop of pink bollworm infestation plaguing cotton farmers.

Even though Monsanto’s second generation insecticidal technology for cotton,was supposed to protect crops against the pink bollworm, the pest has grown resistant to the toxins produced by this trait. As a result,framers now spend more on pesticides to control infestations. This along with the high cost of Bt seeds,is driving framers to indigence.

There are controversies around GM food on several levels, including whether food produced with it is safe, whether it should be labelled and if so how, whether agricultural biotechnology and it is needed to address world hunger now or in the future, and more specifically with respect to intellectual property and market dynamics, environmental effects of GM crops and GM crops’ role in industrial agricultural more generally.

Many problems, viz. the risks of “tampering with Mother Nature”, the health concerns that consumers should be aware of and the benefits of recombinant technology, also arise with pest- resistant and herbicide-resistant plants. The evolution of resistant pests and weeds termed superbugs and super weeds is another problem. Resistance can evolve whenever selective pressure is strong enough. If these cultivars are planted on a commercial scale, there will be strong selective pressure in that habitat, which could cause the evolution of resistant insects in a few years and nullify the effects of the transgenic.

Likewise, if spraying of herbicides becomes more regular due to new cultivars, surrounding weeds could develop a resistance to the herbicide tolerant by the crop. This would cause an increase in herbicide dose or change in herbicide, as well as an increase in the amount and types of herbicides on crop plants. Ironically, chemical companies that sell weed killers are a driving force behind this research (Steinbrecher 1996).

Another issue is the uncertainty in whether the pest-resistant characteristic of these crops can escape to their weedy relatives causing resistant and increased weeds (Louda 1999). It is also possible that if insect-resistant plants cause increased death in one particular pest, it may decrease competition and invite minor pests to become a major problem. In addition, it could cause the pest population to shift to another plant population that was once unthreatened. These effects can branch out much further. A study of Bt crops showed that “beneficial insects, so named because they prey on crop pests, were also exposed to harmful quantities of Bt.” It was stated that it is possible for the effects to reach further up the food web to effect plants and animals consumed by humans (Brian 1999). Also, from a toxicological standpoint, further investigation is required to determine if residues from herbicide or pest resistant plants could harm key groups of organisms found in surrounding soil, such as bacteria, fungi, nematodes, and other microorganisms (Allison and Palma 1997).

The potential risks accompanied by disease resistant plants deal mostly with viral resistance. It is possible that viral resistance can lead to the formation of new viruses and therefore new diseases. It has been reported that naturally occurring viruses can recombine with viral fragments that are introduced to create transgenic plants, forming new viruses. Additionally, there can be many variations of this newly formed virus (Steinbrecher 1996).

Health risks associated with GM foods are concerned with toxins, allergens, or genetic hazards. The mechanisms of food hazards fall into three main categories (Conner and Jacobs 1999). They are inserted genes and their expression products, secondary and pleiotropic effects of gene expression and the insertional mutagenesis resulting from gene integration. With regards to the first category, it is not the transferred gene itself that would pose a health risk. It should be the expression of the gene and the effects of the gene product that are considered. New proteins can be synthesized that can produce unpredictable allergenic effects. For example, bean plants that were genetically modified to increase cysteine and methionine content were discarded after the discovery that the expressed protein of the transgene was highly allergenic (Butler and Reichhardt 1999). Due attention should be taken for foods engineered with genes from foods that commonly cause allergies, such as milk, eggs, nuts, wheat, legumes, fish, molluscs and crustacean (Maryanski 1997). However, since the products of the transgenic are usually previously identified, the amount and effects of the product can be assessed before public consumption. Also, any potential risk, immunological, allergenic, toxic or genetically hazardous, could be recognized and evaluated if health concerns arise.

More concern comes with secondary and pleiotropic effects. For example, many transgenes encode an enzyme that alters biochemical pathways. This could cause an increase or decrease in certain biochemicals. Also, the presence of a new enzyme could cause depletion in the enzymatic substrate and subsequent buildup of the enzymatic product. In addition, newly expressed enzymes may cause metabolites to diverge from one secondary metabolic pathway to another (Conner and Jacobs 1999). These changes in metabolism can lead to an increase in toxin concentrations. Assessing toxins is a more difficult task due to limitations of animal models.

Animals have high variation between experimental groups and it is challenging to attain relevant doses of transgenic foods in animals that would provide results comparable to humans (Butler and Reichhardt 1999). Consequently, biochemical and regulatory pathways in plants are poorly understood.

Insertional mutagenesis can disrupt or change the expression of existing genes in a host plant. Random insertion can cause inactivation of endogenous genes, producing mutant plants.

Moreover, fusion proteins can be made from plant DNA and inserted DNA. Many of these genes create nonsense products or are eliminated in crop selection due to incorrect appearance.

However, of most concern is the activation or up regulation of silent or low expressed genes. This is due to the fact that it is possible to activate “genes that encode enzymes in biochemical pathways toward the production of toxic secondary compounds” (Conner and Jacobs 1999). This becomes a greater issue when the new protein or toxic compound is expressed in the edible portion of the plant, so that the food is no longer substantially equal to its traditional counterpart.

The GM foods have the potential to solve many of the world’s hunger and malnutrition problems, and to help protect and preserve the environment by increasing yield and reducing reliance upon synthetic pesticides and herbicides. Challenges ahead lie in many areas viz. safety testing, regulation, policies and food labelling. Many people feel that genetic engineering is the inevitable wave of the future and that we cannot afford to ignore a technology that has such enormous potential benefits.

Future also envisages that applications of GMOs are diverse and include drugs in food, bananas that produce human vaccines against infectious diseases such as Hepatitis B (Kumar et al. 2005), metabolically engineered fish that mature more quickly, fruit and nut trees that yield years earlier, foods no longer containing properties associated with common intolerances, and plants that produce new biodegradable plastics with unique properties (van Beilen and Yves 2008).

While their practicality or efficacy in commercial production has yet to be fully tested, the next decade may see exponential increases in GM product development as researchers gain increasing access to genomic resources that are applicable to organisms beyond the scope of individual projects ³.

The wide advantages of transgenic crops for a society to solve food security or nutrition security issues have been well established. Many added benefits such as higher nutritional value, herbicide tolerance, virus resistance, tolerance to various abiotic stresses, increase the shelf life of a fruit and thus, can account for a good market for farmers. There is an urgent need for India to carry on its GM crop research program to sustain its food and nutrition security targets.

Debate on GM crops about safe or unsafe will never end although there is hardly any substantial scientific evidence against safety of GM foods. Surprisingly, few public sector intuitions also showed their concerns for GM foods. Intuitions funded by GOI should follow same broad policies of Indian Government and must show their strength with the government to fight poverty and malnutrition. This valid point is raised due to opposite views of the members of Technical Expert Committee appointed by the Supreme Court of India for Safety and Guidelines for GM crop research and make recommendations for future of GM crop research in India.

Although, this is a fact that India does not have basic infrastructure and stringent guidelines for GM crop research and risk assessment but taking in to account India,s urgent need, we cannot halt this program. Ideally, India must continue on its research on GM crop and its deregulation along with building basic infrastructure facilities and preparing stringent biosafety and marketing guidelines. Although portals like GEAC, IGMORIS (Indian GMO Research Information System), Biosafety Clearing House are doing their role for assessing biosafety and their regulation of GM crops but there is an urgent need to build a single window system and online portal for assessment, control, regulations and approval of GM crops.