Genetically modified organisms (GMOs), often termed as creations of ‘modern biotechnology’ or ‘genetic technology’, can be defined as organisms where the genetic material or dioxyribonucleic acid (DNA) has been altered to allow selected individual genes to be transferred from one organism into another – even between non-related species. The initial objective for developing GM plants was to improve crop protection. The GM crops currently in the market are mainly aimed at an increased level of crop protection through the use of one of the three basic traits: resistance to insect damage; resistance to viral infections; and tolerance towards herbicides. (World Health Organisation, www.who.int)
Experts, scientists and lobbyists cite various advantages of genetically modified (GM) plants. Foremost amongst the claims is the elimination of toxic pesticides and chemicals in the crop cycle, as GM produce can be tailored to combat pests – from within. Without pests, crops are healthier and produce bountiful, promising large returns to farmers. Thus despite the seeds being expensive the total cost of production is considerably lower as compared to traditional crops. Also, since GM crops increase yields more food can be produced by farmers. Of course, one may argue that there is enough food for everyone – but unequally distributed. Interestingly GM crops can be genetically altered to grow foods in climatic conditions opposed to patterns established by the plant – for instance plants grown in temperate zones can be engineered to grow in torrid climates. Important cereal crops can be genetically modified to contain higher amounts of important vitamins and minerals – such as Vitamin A, and reportedly taste better. Not only plants, genetic engineering can also alter the growth spurts in fish and other organisms to make them grow faster, and increase shelf life.
On the downside, GM crops pose risks to human health and raise environmental safety concerns. Claims have been made that the potential impact on human health including allergens, transfer of antibiotic resistance markers and outcrossing (the movement of genes from GM plants into conventional crops or related species in the wild) may prove detrimental in the long run. This can also have an indirect impact on food safety and security. It has been reported that contrary to claims, genes inserted into GM food survive the digestive processes even in humans. The outcomes of such survival are still not proven conclusively. Critics of genetically modified food have also pointed out that patent laws related to access and intellectual property rights give developers of the GM crops a dangerous degree of control over food supply. This could potentially lead to domination of world food production by a few companies and increasing dependence of developing countries on industrialized nations – resulting in biopiracy, or foreign exploitation of natural resources. Moreover there are ethical questions related to violation of natural organisms’ intrinsic values and passing animal genes into plants.
Critics have also pointed out that the norms related to safety assessment are not satisfactory for GM foods. The starting point for the safety assessment of genetically engineered food products is to assess if the food is ‘substantially equivalent’ to its natural counterpart. In deciding whether a modified product is substantially equivalent, the product is tested by the manufacturer for unexpected changes in a limited set of components such as toxins, nutrients or allergens that are present in the unmodified food. The data is then assessed by an independent regulatory body. If these tests show no significant difference between the modified and the unmodified products, then no further food safety testing is required. However, if the product has no natural equivalent, or shows significant differences from the unmodified food, then further safety testing is carried out. This method however does not make it clear that what level of similarity makes a GM food ‘substantially equivalent’.
The GM revolution
The first commercially grown GM food crop was tomato (Flavr Savr), modified to ripen without softening by a Californian company Calgene, which took the initiative to obtain approval for its release in 1994. Currently, a number of food crops such as soyabean, corn, cotton, tomatoes, Hawaiian papaya, potatoes, rapeseed (canola), sugarcane, sugar beet, field corn as well as sweet corn and rice have been genetically modified to enhance either their yield, size, or durability, and more. Scientists are also working on crops which they hope will be useful for industry, such as plants that produce oil for the cosmetics industry, crops with altered nutritional value, and even crops that produce pharmaceutical drugs. Major producers of transgenic crops include USA, Argentina, Brazil, India, Canada, China, Paraguay, South Africa, among others. The biggest producer of GM crops is the USA where four main crops grown are soya bean, maize, cotton and oilseed rape. (www.nerc.ac.uk)
The Rules in India
Norms related to application of biotechnology in agriculture is being undertaken by the Ministry of Agriculture (MoA), Ministry of Environment and Forests (MoEF); and Department of Biotechnology (DBT); however the legislative framework on agro-biotechnology rests mainly with the MoEF. Under the Environment (Protection) Act, 1986, the MoEF has notified the rules for manufacture, use, import, export and storage of hazardous micro organisms/genetically engineered organisms or cells, (Rules 1989). These cover the areas of research as well as large scale applications of GMOs and such products throughout India and identifies six competent authorities – Recombinant DNA Advisory Committee (RDAC); Institutional Biosafety Committees (IBSC); Review Committee on Genetic Manipulation (RCGM); Genetic Engineering Approval Committee (GEAC); State Biotechnology Coordination Committee (SBCC); and District Level Committee (DLC) to oversee GM related activities in the country. Further, the Department of Agriculture and Cooperation (DAC), MoA had set up a task force under the Chairmanship of Prof M S Swaminathan to formulate a long term policy on Application of Biotechnology in Agriculture in 2003. The Swaminathan Task Force recommended the establishment of an autonomous, statutory and professionally led National Biotechnology Regulatory Authority (NBRA). In 2007 the Government formulated the National Biotechnology Development Strategy in accordance with the recommendation. The stated vision of the Strategy is the responsible use of life sciences and biotechnology to promote balanced growth of all sections of the society. DBT has been entrusted with setting up of NBRA, which is envisaged to be an independent, autonomous and professionally led body to provide a single window mechanism for biosafety clearance of genetically modified products and processes. This would be done through the promulgation of a new legislation, the National Biotechnology Regulatory (NBR) Act. Draft establishment plan of the NBRA and a draft NBR Bill, 2008 have been prepared by a Consultative Committee on which the DBT has invited feedback from all the concerned stakeholders.
Regulation of genetically engineered crops is extremely important to address the biosafety concerns associated with these products. The international food code or the Codex Alimentarius (The Codex Alimentarius Commission (Codex), 1963 is the joint Food and Agriculture Organization (FAO) / World Health Organization (WHO) body responsible for compiling the standards, codes of practice, guidelines and recommendations that constitute the code. The premise of the principles dictate a premarket assessment, performed on a case-by-case basis including an evaluation of both effects from the inserted gene and unintended effects that may arise as a consequence of insertion of the new gene has been used as a point of reference. In India, athough the Rules 1989 cover areas of research as well as large scale applications of GM crops, however, with continuous advancements fresh guidelines have been framed from time to time. Some of these are – Recombinant DNA Safety Guidelines, 1990 by DBT covering research in biotechnology, field trials and commercial applications; Revised Guidelines for Research in Transgenic Plants, 1998 by DBT; Protocols for Food and Feed Safety Assessment of Genetically Engineered Crops, 2008 by DBT; Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 by Indian Council of Medical Research (ICMR); and, Guidelines and Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered Plants, 2008 by DBT and MoES. The Government of India follows a policy of case-by-case approval of transgenic crops. As per the guidelines framed by the ICMR, safety assessment is designed to identify whether a hazard, nutritional or other safety concern is present, and if present, to collect and analyze information on its nature and severity.
Bt cotton refers to transgenic cotton which contains endotoxin protein inducing gene from soil bacterium Bacillus thuringiensis. The first transgenic plant – tobacco, was developed in USA followed by cotton in 1987 by Monsanto, Delta and Pine companies. In India the Maharashtra Hybrids Seed Company (Mahyco) jointly with the US seed company Monsanto developed Bt Cotton to tackle the bollworm problem that had devastated cotton crops in the past. In 2002, Bt Cotton, marketed by the Monsanto-Mahyco joint venture, became the first and only transgenic crop approved by the GEAC for commercial cultivation in six states – Andhra Pradesh, Gujarat, Karnataka, Madhya Pradesh, Maharashtra and Tamil Nadu. It has been further extended to Punjab and Haryana.
Though public opinion has been divided on the issue, the Government has indicated satisfactory performance of Bt Cotton. As per the Government figures, the area under Bt Cotton has increased from 0.70 lakh acres in 2002 to 93.36 in 2010-11. Also a total of 46 Bt hybrids were approved in the year 2012. (Parliament Question 5122, 8.05.2012)
While on the one hand the ‘Bt Cotton Revolution’ – with transgenic cotton reportedly being grown in 90 per cent of the cotton growing areas, increasing yields by as much as 50 per cent in certain regions has taken the country by storm – on the other critics from civil society groups are unconvinced. They have contested the claim adding that Bt Cotton cultivation has resulted in adverse economics for farmers – with highly priced seeds, changed pest ecology in cotton fields, increased incidence of diseases (requiring more pesticides to control these), unpredictable crop performance and more resources being used by farmers as part of their risk insurance mechanisms (use of more irrigation, fertilizers, etc.). Stress tolerance of the Bt Cotton, such as surviving adverse weather conditions, has been said to be very low. There have also been reports of adverse impact on soil, human health (allergic symptoms) as well as toxicity in animals grazing on the Bt Cotton fields. Moreover claims are being made that large scale contamination and rapid proliferation of various illegal varieties is underway.
Brinjal or aubergine is one of India’s most popular vegetables. Grown in small plots as a cash crop, the main growing areas of Brinjal are Andhra Pradesh, Bihar, Karnataka, Maharashtra, Odisha, Tamil Nadu, Uttar Pradesh and West Bengal. It is estimated that the damage caused by the fruit and shoot borer, which has been the major pest for the past two decades or so, ranges from 50 to 70 per cent. It is to lend tolerance to this pest primarily that the Bt Brinjal has been developed. It is reported that upon the ingestion of the Bt toxin by the insect, there would be disruption of digestive process, resulting in its death. In 2009 the GEAC cleared Bt Brinjal – country’s first genetically modified food – for commercial use. However, amidst protests and campaigns by the anti GM groups, the Government is yet to take a final call.
In India, arguments that favoured the introduction of Bt Brinjal are – no significant differences between Bt- and non-Bt Brinjal as per biosafety tests have emerged – like acute oral toxicity; sub-chronic oral toxicity in rats; allergenecity of protein to rats; germination; weediness and aggressiveness tests; soil studies; etc. Also scientific claims assert that Bt, a naturally occurring bacterium are lethal only in the acidic insect gut and do not get activated in an alkaline environment, prevalent in humans and other animals that feed on these plants. Moreover, pricing of the seeds would be based on a cost recovery model, making it affordable for all farmers – and they would be able to save and reuse their seeds for hybrids.
However, arguments propagated against Bt Brinjal enumerate that the current safety assessments are inadequate as GM technology is unpredictable and imprecise. Moreover, activists argue that the regulatory regime in India with regard to the GM crops has never been assessed thoroughly with regard to the GM risk assessment in Indian conditions. Several studies in Bt crops show that there are many potential health hazards, as in the case of Bt cotton where allergies have been reported. Many claim that there has been a significant decline in the fertility and milk yield of cattle with GM cottonseed cattle feed. Also Bt toxin has caused powerful immune responses and abnormal cell growth in mice. Farmers from various parts of the country have reported a decline in their soil productivity after growing Bt cotton. Apprehension has been expressed that the target pest would grow resistance to the Bt toxin with time and pesticide use would not substantially fall as the technology would only take care of fruit and shoot borer, while other pests like aphids, jassids and white fly apart from problems like fungal disease would remain. It is also surprising that a crop such as GM Brinjal should be cleared for production when more often than not there is surplus production in the crop leading to a glut. Also several other issues related to patenting and pricing remains ambiguous and litigative.
Other GM Crops
As per the Indian GMO Research Information System (IGMORIS), GM crops, apart from Brinjal that are being currently tested are cabbage and cauliflower for insect resistance; potato for transgenic dwarf potato, disease resistance, reduction in cold induced sweetening and colour improvement; cotton for insect resistance and herbicide tolerance; corn for insect resistance and herbicide tolerance; rice for insect resistance; groundnut for virus resistance; and sorghum for insect resistance. According to the available information with the Indian Council for Agricultural Research (ICAR), genetic modification is currently being carried out in 72 crops. (Parliament Question 4267, 20.12.2011)
Genetic engineering and its application in agriculture involve far too many questions. As the FAO pointed out in 2004, “Science cannot declare any technology completely risk free…”. It is well understood that GM foods have the potential to solve hunger and malnutrition problems, and can help protect and preserve the environment by increasing yield and reducing reliance upon chemical pesticides, yet it must be dealt with caution. There are many unresolved challenges especially in the areas of safety testing, regulation, industrial policy and food labelling which necessitates a watch and go policy.
Inputs from: Genetically modified crops: Issues and Challenges in the context of India; Research Unit; Rajya Sabha Secretariat, 2009.