1.0 GENETIC MODIFIED ORGANISMS (GMOs)
Current and emergent uses of biotechnology in crops, livestock, forestry and fisheries include a wide series of traditional, conventional and molecular tools, including genetic modification (GM) techniques. Some of these tools are specifically applied within the green sector, while some are also applied within the blue, red or white sectors.  None of these tools are panaceas for solving the challenges faced by developing countries, which are not only to feed more people, but to do so with rapidly diminishing natural resources available (land, water, energy) and fewer people employed in primary agriculture. Some of the technologies do, however, hold promise as tools (merely tools but important tools) for addressing some of the problems to be solved by developing countries during the next decades. At the same time some of the tools pose dangers (real or perceived) in terms of their safe and responsible usage that needs to be addressed. 
There is a lot of misunderstanding when it comes to Genetic Engineering. Firstly, scientists do not willy-nilly throw some random genetic sequences into an organism and see if it works. They remove specific genes from organisms and implement them into another organism, no gene is created randomly, and it is transferred from one species to another. Therefore claims that they will be dangerous as they already exist in nature and their biochemical properties are very well understood. Secondly, saying that they aren't natural is void of any logic.

2.0 GENETICALLY MODIFIED (GM) PLANTS AND FOOD CROPS 
Genetically modified or "GM" crops are being considered as having the potential to bring about the second green revolution.  India is currently working on 111 transgenic crop varieties of various vegetables, fruits, spices, cereals, bamboo etc. Transgenic crops brinjal, cabbage, castor, cauliflower, corn, groundnut, okra, potato, rice and tomato are under field trials stage. But it is cotton which was the first GM crop to be extensively worked upon & commercially released in India; the reason being that India has the largest area under cotton cultivation in the world.

The use of GM in plant breeding aims to: 

• Increase crop yields beyond the maximum for existing varieties 
• Reduce post-harvest losses 
• Make crops more tolerant of stresses (crops, drought, salt, heat) 
• Make crops that do not exhaust soil fertility (make more better use of nitrogen, phosphorous etc.) 
• Improve nutritional value of foods 
• Reduce reliance on chemical pesticides by producing pest resistant crops 
• Develop alternatives for industry such as starches, fuels, and pharmaceuticals

Some of these aims involve transferring genes across species in a way that cannot be done by plant breeding. Whether it is SAFE to do this depends on which genes are being transferred, and this is addressed by safety assessments and regulations whether it is ETHICAL to do so raises a different set of questions.

Most GM crops grown today have been developed to resist certain insect pests. There are GM plants being developed today to produce specific vitamins, resist plant viruses and even produce products for medical uses. Countries that grow GM crops include; Argentina, Australia, Canada, China, Germany, India, Indonesia, Mexico, Portugal, South Africa, Spain, United States, Ukraine, and many more.

2.1 Scenario of GM crops in India: 
In India the first transgenic crop (Bt Cotton) was cleared for cultivation in the year 2002. Within a span of seven years the area under Bt cotton cultivation has gone beyond 7.6 million hectares and it constitutes approximately 82% of the total cotton area of the country. Important states where Bt cotton is grown extensively include Maharastra (3.13 million hectares- representing almost half of 42% of Bt cotton area in India) followed by Gujarat (1.36 million hectares), Andhra Pradesh (1.32 million hectares), Madhya Pradesh (620,000 ha). It is claimed that with the introduction of Bt cotton in India and with rapid expansion of its area, India got transformed from a net importer to a net exporter of cotton. Export of cotton registered a sharp increase from a meagre 0.05 million bales in 2001-02 to 8.5 million bales in 2006-08.
Field trial on 10 crops (brinjal, cabbage, castor, cauliflower, corn, groundnut, okra, potato, rice and tomato) is going on at present in India. After Supreme Court lifted its restriction on experimental field trial of GM crops in 2008, the Apex Regulatory Body - Genetic Engineering Approval Committee (GEAC) has recommended for the field trial of Bt brinjal in the country. If it is allowed by government for its commercial cultivation it will be the first GM food crop to be cultivated in open environment in India. The first transgenic plants in India were developed at BARC.

2.2 GM crops and food security 
Arguments about whether genetically modified crops can increase food security for farmers and consumers in the developing world have been at the heart of debates about agricultural biotechnology for over a decade. Opponents of GM farming believe that the technology’s failure to produce a decisive breakthrough on this front to date is proof that the technology’s potential has been inflated by an overblown hype that has been built on a number of doubtful assumptions about the role of technology in “feeding the world”. For their part, advocates of GM crops argue that important new benefits are just around the corner, and urge a quicker and more enthusiastic embrace of GM crop technology. 
These debates about biotechnology and its potential contribution to food security revolve around issues of access and control – especially the roles played by public and private sectors, and the effects of intellectual property rights (IPRs), in shaping the types of biotechnologies that are developed and how they are made available.
Some critics argue that the enthusiasm for genetically modified crops reflects a fixation with the quick fix – technological “silver bullets” that can overcome problems which are actually rooted in social, economic and political institutions and structures. Others believe that obstacles to the free flow of knowledge and technology, which are imposed by restrictive IPRs, hamper the efforts of scientists working to develop “pro-poor” biotechnologies for farmers in the developing world.
But many international organizations and aid donors take the position that, if the public and private sectors can work in complementary ways, in a context where IPRs are properly protected and technologies can be licensed for use, it will be possible to develop new types of GM crops and other biotechnologies that will more directly address the needs of farmers and consumers in the developing world.

3.0 DEBATE ON GMOs
Should we be doing genetic modification? 
Some Christians object in principle to genetically modified foods as an unacceptable intervention in God’s creation, violating barriers in the natural world. Others think using God’s gift of our technical skills to change one or two genes is not wrong in itself, unless the change caused a major disruption in the organism. Such basic changes in genes and food require due precaution on food safety and environmental risk, but not out of proportion. SRT has an information sheet on GM animal issues.
GM soya and maize imports used to make soya oil and maize flour used for many processed foods. The companies refused to segregate supplies or label products as GM, being more concerned with winning markets than public attitudes. Questions were also raised about potential risks to health, gene flow to non-GM crops, and a loss of biodiversity. When people realized they were eating GM foodstuffs whether they liked it or not, with perceived risks but no tangible benefits, and with no say in the decisions, a consumer backlash wasn’t surprising.

Will genetic engineering really ‘feed the world’? 
Many people are concerned that the driving forces of biotechnology create products for western indulgences, neglecting real food shortages elsewhere in the world. The causes of hunger are more about poverty, war, and political and social issues than inefficient production. Often better answer may come from better breeding with indigenous resources, than high tech solutions. Yet GM might help in some situations. GM vitamin-A rice might help malnourished communities with no access to fresh vegetables. If genes could be altered to enable staple crops to grow in marginal conditions, it might make differences to countries which struggle to feed themselves. But useful applications are often hard to engineer and offer no profits to private industry. GM has so far mostly been rich man’s technology. To be serious about ‘feeding the world’ means radically reorienting research investment to put top priority on meeting the specific needs of marginal agriculture, using diversity of old and new technologies. GM might be one tool amongst many.

Superweeds

Spread of genes from GM crops that are resistant to a herbicide could create weeds that are resistant to it
Some conventionally bred crop varieties and weeds are already herbicide-resistant. If GM crops led to herbicide-tolerant weeds they would be tolerant only to that herbicide and could be controlled by others if required. Many wild weeds in the countryside are never sprayed, so whether or not they contain a gene for herbicide tolerance does not affect them. Scientists are currently comparing the behaviour of a non¬-GM non-tolerant variety and a GM tolerant variety to determine optimal management strategies.

GM crops might grow as weeds (volunteers). 
In UK trials, herbicide-tolerant GM oilseed rape does not appear to pose any more problems than convention¬ally bred varieties. Many crops are relatively poor competitors: wheat for example can only survive for about 2 years in the wild.

GM crops that are resistant to insect pests might deplete pest populations and damage the natural food chain. 
Any form of pest control e.g. mechanical, chemical, organic or GM has the potential to deplete pest numbers and so impact on the food chain. GM crops could be designed so that they switch on the gene that protects against pests only when the crop is under severe attack by the pest. or only when it is sprayed by a harmless compound. This would prevent depletion of pest populations.

GM crops that are resistant to insect pests might accelerate the evolution of pests to overcome this resistance. 
Resistant pests evolve in response to any control method. Careful and limited use of spraying and using different sprays in rotation are among the strategies already employed by farmers to minimise this effect. With GM crops there is the potential to use two or more different genes that confer resistance against a pest in tandem in a crop. This would make it much harder for pests to overcome the resistance because they would need to evolve two or more changes at the same time. Alternatively farmers could rotate crops that each contains a different gene conferring resistance against the pest. Scientists are exploring the use of' refuge areas of non-GM plants in and around GM crops, in which populations of pests would be free from any pressure to evolve resistance.

GM crops that are resistant to insect pests might be harmful to other species. 
Scientists are conducting laboratory and field trials to study the impact of insect-resistant GM crops on interactions between the plant, its pests and the pest's predators or parasites. The genes used in current GM insect-resistant crops code for natural compounds produced by the bacterium Bocillus thuringiensis (Br) that are used in sprays approved for use in organic farming. These compounds are highly specific: for example, the agent against butterfly and moth larvae does not affect bees.

GM food consumer security 
Fears have been expressed that: GM foods might result in unexpected health hazards such as novel allergens, or transfer of antibiotic resistance from marker genes in GM crops to bacteria that live in the human gut. 
Allergens can be introduced through conventional breeding. Tests are used routinely to detect and eliminate them. The same tests could be used with GM foods. GM technology could be used specifically to eliminate known allergens from foods. 
Foods derived from GM crops may or may not contain any of the inserted gene or the protein for which it codes - it depends on the type of food. Technically it is becoming possible to produce GM crops in which the inserted gene would be active only in non-edible parts of the plants, where this would be appropriate. 
Concerns about the long-term dietary effects of eating novel pieces of DNA apply equally to new varieties bred by conventional breeding. As all DNA is made up of the same four building blocks, and DNA sequences are broken down into short pieces of DNA by enzymes in the gut, it is inconceivable that novel combinations of these building blocks would be more likely to arise from GM than non-GM plants. Conventional, non-GM foods carry many unidentified microbial genes, which are consumed along with the genes of the plant or animal material.

GM crop farmer security 
The GM seeds cannot be produced by the poor farmers; it can only produced by a few multinational agrochemical corporations. 
GM crops might show unexpected properties and might not breed true. Laboratory studies on a range of crops have shown that genes inserted by genetic modification into plants are stable, perform predictably and are inherited normally. Just like conventional plant breeding, genetic modification may produce some offspring with unstable and undesirable characteristics. In both cases, these can be identified and eliminated from breeding lines. 
Scientists have identified mechanisms by which genes inserted by genetic modification may very rarely get switched off. They are developing options for more precise regulation of inserted genes. (GM agriculture in the UK? Published in 1999 by the Biotechnology and Biological Sciences Research Council's (BBSRC)).

Can GM crops help eradicate poverty? 
Nearly 800 million people go hungry every day because they cannot grow or buy enough food. One in seven children born in the countries where hunger is most common die before they are five years old.  Many governments, companies and institutions are promoting genetically modified (GM) crops as a response. It’s claimed GM technologies will increase food production, reduce environmental degradation, provide more nutritious foods and promote sustainable agriculture. 
It is not the interests of poor farmers but the profits of the agrochemical industry that have been the driving force behind the emergence of GM agriculture. Four multinational corporations – Monsanto, Syngenta, Bayer Crop Science and DuPont ¬now control most of the GM seed market in the world. Some 91% of all GM crops grown worldwide in 2001 were from Monsanto seeds. By linking their chemicals to seeds via GM technologies, these corporations have been able to extend markets for their herbicides and pesticides.
GM crops are unlikely to help eradicate poverty because yields seem to be no more than non-GM crops and sometimes need more chemicals. Yields from GM soybeans are no higher than those from high-yield conventional varieties. In one study, Monsanto's GM soya had 6% lower yields than non-GM soya and 11 % less than high-yielding non-GM soya.
Insecticide use on GM cotton has fallen in some locations, but these gains may be short-lived as insects develop resistance to the insecticide that the cotton expresses. In time, farmers may need to invest in more, not fewer, chemicals. This also applies to chemical use on herbicide¬ resistant GM crops, which has gone up rather than down as farmers use chemicals more frequently and/or in greater amounts. Herbicide use per hectare in Argentina has more than doubled on GM fields compared to conventional varieties.
GM crops are ineffective in tackling the underlying political and economic causes of food insecurity: poverty and inequality. The new GM technologies do not address the essential constraints facing poor farmers including lack of access to land, water, energy, affordable credit, agricultural training, local markets, decent roads, grain stores and infrastructure. In fact, GM could be disastrous for small-scale farmers as the costs are much higher and they risk falling into debt

Do GM crops meet the needs of poor farmers? 
GM varieties do not meet the needs of poor farmers who rely on affordable, readily available supplies of seeds for a range of crops to meet diverse environmental consumption and production needs. Poor communities need investment in low cost, low-input farmer-friendly technologies, building on farmers' knowledge. GM seeds, by contrast, are targeted at large-scale commercial farmers growing cash crops in monocultures. GM crops could undermine food security by wasting the scarce resources of poorer farmers and developing countries.
Most research and development in GM agriculture is conducted by the private sector. Less than 1 % of all GM research is directed at poor farmers. 
GM research in Africa, for instance, focuses on export crops such as cut flowers, fruit, vegetables, cotton and tobacco, which are grown in large-scale commercial plantations in Kenya. South Africa and Zimbabwe. In Kenya, only one out of 136 intellectual property applications for plants were for a food crop; more than half were for roses.

Do GM threaten basic rights? 
Farmers in developing countries have evolved complex, cheap and effective systems to save, exchange and use seeds from one harvest to the next. Patented GM seeds threaten to erode these rights and practices, to displace or contaminate seed supplies, and to increase farmers' dependence on private monopolised agricultural resources.
Up to 1.4 billion people, including up to 90% of farmers in Africa, many of them women, depend on saved seed. Yet the proliferation of intellectual property regimes that comes with GM seeds threatens centuries-old practices of saving and exchanging seeds.
GM seeds must usually be bought each season. Before they can obtain and use the seeds, farmers have to sign a contract with the company obliging them to pay a royalty or technology fee, to agree not to save or replant seeds from the harvest, to use only company chemicals on them and to give the corporation access to their property to verify compliance.
Having to buy external supplies of seeds and pesticides leaves farmers more economically and agriculturally dependent on corporations. The technology fee makes such seeds prohibitive for the poorest farmers who lack access to credit. The contracts are complex and easily misunderstood by farmers, especially those who are illiterate.

The biotech industry continues to develop a set of GM crop technologies - Genetic Use Restriction Technologies (GURTs), which have been dubbed 'terminator technologies' - that produce sterile seeds: if saved and planted from one year to the next, they would have no yields at all.
The widespread adoption of GM crops seems likely to exacerbate the underlying causes of food insecurity Developing country governments are under huge pressure to accept GM crops, put scarce public resources into GM research and open their doors to biotech corporations before their people have been properly informed, consulted and agreed to accept, or reject, GM. Poorer farmers and communities are being sidelined in debates and decisions about GM technology.
In South Africa, for example, GM crops have been planted without prior public consultation or involvement in decision-making and without environmental studies on their impact.
If GM research takes place in the public sector it may not address the needs of poor farmers because most genes and processes are now patented by corporations. In partnerships between public research organizations and corporations, control and decision-making tend to remain firmly in the hands of corporations who acknowledge that their goal is to create new markets and improve their public image. If poorer people were more involved in setting agricultural research agendas, they would probably opt not for GM crops, bur for other agricultural solutions.

4.0 IMPACT OF GM CROPS ON BIODIVERSITY 

The potential impact of genetically modified (GM) crops on biodiversity has been a topic of general interest as well as specifically in the context of the Convention on Biological diversity. Agricultural biodiversity has been defined at levels from genes to ecosystems that are involved or impacted by agricultural production. After 15 years of commercial cultivation, a substantial body of literature now exists addressing the potential impacts of GM crops on the environment. This review takes a biodiversity lens to this literature, considering the impacts at three levels: the crop, farm and landscape scales. Within that framework, this review covers potential impacts of the introduction of genetically engineered crops on: crop diversity, non-target soil organisms, weeds, land use, non-target above-ground organisms and area-wide pest suppression. The emphasis of the review is on peer-reviewed literature that presents direct measures of impacts on biodiversity. In addition, possible impacts of changes in management practices such as tillage and pesticide use are also discussed to complement the literature on direct measures. The focus of the review is on technologies that have been commercialized somewhere in the world, while results may emanate from non-adopting countries and regions. Overall, the review finds that currently commercialized GM crops have reduced the impacts of agriculture on biodiversity, through enhanced adoption of conservation tillage practices, reduction of insecticide use and use of more environmentally benign herbicides and increasing yields to alleviate pressure to convert additional land into agricultural use.

5.0 TYPES OF BT CROPS

What is Bt? 
Bacillus thuringiensis (Bt) is a spore forming bacterium that produces crystals protein (cry proteins), which are toxic to many species of insects. Three Bt transgenic crop species (cotton, corn and potato) have already been commercialized with substantial benefits to farmers. So much so that in 2008 Bt crops occupied an area of 43 million hectares out of the global transgenic area of 125 million hectares. Bt cotton was commercialized in India in year 2002 and has been a spectacular success story

History of Bt 
Japanese biologist, Shigetane Ishiwatari was investigating the cause of the sotto disease (sudden-collapse disease) that was killing large populations of silkworms when he first isolated the bacterium Bacillus thuringiensis (Bt) as the cause of the disease in 1901. Farmers started to use Bt as a pesticide in 1920. France soon started to make commericialized spore based formulations called Sporine in 1938. Sporine, at the time was used primarily to kill flour moths.

Where is Bt found? 
Bt can be found almost everywhere in the world. Surveys have indicated that Bt is distributed in the soil sparsely but frequently worldwide. Bt has been found in all types of terrain, including beaches, desert, and tundra habitats.

How many kinds of Bt are there? 
There are thousands of different Bt strains, producing over 200 cry proteins that are active against an extensive range of insects and some other invertebrates.

What type of bacteria is Bt? 
Bt belongs to the family of bacteria, Bacillus cerus (B. cerus). B. cerus strains produce toxins that cause gastroenteritis (food poisoning) in humans. Bt is differentiated from B. cerus because it contains a plasmid (flash animation) that produces the protein crystals that are toxic to insects. Bt does not cause food poisoning.

Where is Bt used?
Bt is largely used in agriculture, especially organic farming. Bt is also used in urban aerial spraying programs, and in transgenic crops. To learn more about each of these topics, click on the corresponding link on the left.

How does Bt work? 
Bt has to be eaten to cause mortality. The Bt toxin dissolve in the high pH insect gut and become active. The toxins then attack the gut cells of the insect, punching holes in the lining. The Bt spores spills out of the gut and germinate in the insect causing death within a couple days.

What are Bt crystals?
Bt crystals, sometimes referred to as insecticidal crystal proteins (ICP), are protein crystals formed during sporulation in some Bt strains. Bt produces proteins that aggregate to form a crystal.

These crystal proteins are toxic to very specific species of insects yet harmless to humans and the natural enemies of many crop pests (benenificial insects). There are more than 150 insects that are known to be susceptible in some way to Bt.

The crystal proteins bind specifically to certain receptors in the insect's intestine. Not all insects carry the same receptors allowing for high species specificity. Humans and other vertabrates do not have these receptors in their bodies, so the toxin is unable to affect us.

5.1         Bt Cotton 
India got its first approval of genetically modified crop Bt cotton hybrid “Bollgard” in 2002. The total cultivated area under GM crops has increased many folds since then with India (6.2 million hectares) standing at 5th position (ahead of China) in Bt cotton production. The US-registered multinational corporation, Monsanto, first developed Bt cotton and the three genetically modified cotton hybrids (Bt Mech 12, Bt Mech 162 and Bt Mech 184) developed by Monsanto in collaboration with its Indian partner Mahyco were released for commercial cultivation in central and southern India. The scenario has changed dramatically, largely due to the adoption of Bt cotton. The number of Bt hybrids released for commercial cultivation till date has crossed 600 with more than 35 seed companies and public sector institutions currently engaged in their development. In addition, the first true breeding variety has also been released by the Indian Council of Agricultural Research (ICAR), a public sector institution. This provides an opportunity to the farmers to save their own seed without losing the efficacy of Bt gene. The area under Bt cotton reached 7.6 million hectares in 2008-09 constituting nearly 81% of the total cotton area in India. As a result, the production also reached 4.9 million tonnes. All these are indicators of the extraordinary impact and acceptance of Bt technology in cotton by the Indian farmers. This is quite comparable to the success of dwarf varieties of wheat and rice during the Green Revolution period. Several studies have established considerable economic benefits of Bt cotton cultivation to the farmers of all strata. Another significant development relates to creation of enabling environment by the Government of India. The Ministry of Environment and Department of Biotechnology simplified the regulatory procedures leading to expeditious commercial release, especially of events with well established biosafety record (Fig. 1,a,b)

5.2.        Bt Bringal 
Brinjal or baingan, known as eggplant and aubergine in North America and Europe respectively, is a very important common man’s vegetable in India. It is often described as a poor man’s vegetable because it is popular amongst small-scale farmers and low income consumers. A poor man’s crop it might be, but brinjal is also called by some as the ‘King of Vegetables’. It is featured in the dishes of virtually every household in India, regardless of food preferences, income levels and social status. Low in calories and high in nutrition, the vegetable has very high water content and is a very good source of fiber, calcium, phosphorus, folate, and vitamins B and C. It is also used in ayurvedic medicine for curing diabetes, hypertension and obesity. In addition, dried brinjal shoots are used as fuel in rural areas. Brinjal has embedded itself deeply into the Indian culture. Numerous folk songs in Indian languages center on the humble vegetable. 
The remarkable success of Bt cotton in India, which now occupies 80% of the 9.4 million hectares planted to cotton in the country, is a clear demonstration that biotechnology can be harnessed to contribute to alleviation of poverty and hunger. The development of Bt brinjal, the first biotech vegetable crop, is an appropriate and timely step because it will further demonstrate the significant benefits that biotechnology offers farmers, consumers and India as a nation 
Genetically engineered Bt brinjal and the implications for plant biodiversity – revisited, an independent study commissioned by Greenpeace International, finds that brinjal relatives do occur in the regions where cultivation of GE Bt brinjal is proposed, and that GE Bt brinjal may mate with these relatives to spread the GE Bt gene. Spread of the GE Bt gene would have considerable ecological implications, as well as implications for future crop contamination and farmers' rights.

5.3.        Bt Corns 
Bt corn is a genetically modified organism (GMO) which has been bioengineered to resist the European corn borer, a crop pest which can cause significant damage to crops. Many nations plant Bt corn, and this corn is in use in a variety of industries. Studies conducted on this GMO seem to suggest that it has no adverse human health effects, leading many government agencies to certify it as safe for use. This corn takes advantage of a toxin produced by the Bacillus thuringiensis bacterium. The toxin, known as Bt, ruptures the intestines of the corn borer and related organisms when it is ingested. The pests typically die within two to three days of ingesting the toxin.
It is a variant of maize, genetically altered to express the bacterial Bt toxin, which is poisonous to insect pests. In the case of corn, the pest is the European corn borer. Over the past couple years they have added traits against Corn ear worm, and Root worm. Expressing the toxin was achieved by inserting a gene from the microorganism Bacillus thuringiensis into the corn genome. This gene codes fora toxin that causes the formation of pores in the Lepidoptera larval digestive tract. These pores allow naturally occurring enteric bacteria, such as E. coli and Enterobacter, to enter the hemocoel, where they multiply and cause sepsis. (Fig. 2)
India is among the top five of the 30 countries worldwide that have taken to GM technology. Currently, India grows only one crop — Bt cotton — on a commercial scale, while research for genetic modification of several other crops — grains, oilseeds, vegetables, etc — is going on. Corn or maize is one of them. Stem borer is the biggest threat to maize crop.

Fig. 2: General schematic view of GM crop development

But many international organizations and aid donors take the position that, if the public and private sectors can work in complementary ways, in a context where IPRs are properly protected and technologies can be licensed for use, it will be possible to develop new types of GM crops and other biotechnologies that will more directly address the needs of farmers and consumers in the developing world.

                Fig. 1a                                           Fig. 1b

Even though the toxin does not kill the insect immediately, treated plant parts will not be damaged because the insect stops feeding within hours. Bt spores do not spread to other insects or cause disease outbreaks on their own. (Fig. 3)

1. Insect eats Bt crystals and spores.

2. The toxin binds to specific receptors in the gut and the insects stops eating.

3. The crystals cause the gut wall to break down, allowing spores and normal gut bacteria to enter the body.

4. The insect dies as spores and gut bacteria proliferate in the body.

Fig. 3: Action of Bt proteins on insects

6.0 GM RISK & BENEFIT:

6.1 Effects on health
Independent studies on the wholesomeness of GM crops for either animals or humans are severely lacking from scientific literature. Almost all GMOs commercialised in the world either produce or tolerate pesticides. Yet while pesticides are tested over two year periods prior to approval in Europe, the longest safety tests for GMOs are 90 days, including pesticide-producing GM plants. We simply do not know if GM crops are safe for animal or human consumption, because long-term studies have seldom been performed. This is reflected by the ongoing controversy surrounding their safety assessment. The dispute over the pesticide-producing Bt maize MON863, for example, arose from concerns expressed by independent scientists over observed differences in animal feed trials. Rather than admitting uncertainty concerning the food safety of MON863 and carrying out further research, EFSA and the biotechnology industry have used their efforts to try to refute the significance of these findings. It is ungrounded and misleading to argue that GMO must be harmless to health on the grounds that people living in the US have been consuming them for 10 years and no visible damage has been observed. There has not been a study on this specific matter. What is not in doubt is that GM crops have the potential to cause allergenic reactions, more so than conventional breeding. During a long-term field trial in Australia, for example, GM peas were found to cause allergenic reactions in mice. Eating the GM peas also made the mice more sensitive to other food allergies.(Department of Biotechnology, Government of India, New Delhi.)

Table – 1: Risk associated with genetically modified (GM) food

 

There are three types of harmful effects caused by pesticides: acute effects, delayed effects, and allergic effects. Acute effects are injuries or illnesses that appear immediately after exposure. The effects are usually obvious and reversible if appropriate medical care is given right away. Delayed effects are illnesses or injuries that do not appear immediately. these include cancer. There are over 160 synthetic pesticides that are listed to be possible carcinogens. Many of these pesticides are still in use. The US EPA has classification systems that identify carcinogens. The European Union does not have any list available on carcinogenic pesticides. Pesticides have been known to cause lymphoma, leukemia, breast cancer, asthma, and other immune system disorders.
Allergic effects are harmful effects that some but not all people develop in reaction to substances stated below:

Bt Strain	Effective against
Bt kurstaki (Btk)	types of lepidopterous insects gypsy moth cabbage looper
Bt aizawai (Bta)	wax moth larvae in honeycombs
Bt israelensis (Bti)	mosquitoes, blackflies, midges
Bt san diego	certain beetle species, bool weevil

Bt is effective only when eaten by the insect as a larva, Bt is ineffective against most adult insects. Since Bt is applied topically, insects that attack the roots or the insides of a plant will not be affected.

 

6.2 Insect Control:
Aerial sprayings in urban areas is commonly conducted to reduce levels for certain pests or to contain disease-carrying insects. There are many chemicals used in urban insect control. Sometimes these chemicals are harmful to humans.

The use of chemical pesticide DDT was widely used in urban aerial sprays to control urban mosquito, gypsy moths, Japanese beetle and other insects in the 1940's. By 1972, DDT was banned from the United States due to widespread development of resistance to DDT and evidence that DDT use was increasing preterm births and also harming the environment.

Today, there are more than 500 species of insects and mites that are resistant to some form of pesticides. As a result of the increasing resistance, countries have started to apply more products, combine pesticides, increase applications, or substitute with more toxic replacements.

 

Safety with Bt urban aerial spraying
Bt has been found through rigorous testing to be harmless to humans, other mammals, fish, birds, or basically all vertebrates. Many countries in the world have incorporated Bt aerial spraying into their pest control program. Bt products are used on millions of acres of wooded areas and agricultural crops. These spays are used to control for gypsy moths, blackflies, mosquitoes, and many other pests in forestry and urban areas.

Tests conducted during spraying over urban areas in Canada and the US showed no negative effects on humans. There was no correlation between the aerial application of Bt and the short-term health effects in the adult population, or in aggravation of asthma symptoms in children

 

6.3 Benefits of Bt-crops
The International Service for the Acquisition of Agri-biotech Applications (ISAAA) conducted a detailed survey of the Bt-cotton cultivation, adoption and performance in eight countries (USA, Australia, China, India, Mexico, Argentina, South Africa and Indonesia) in 2002 (James, 2002). All the countries that have introduced Bt cotton have derived significant and multiple benefits. These include increases in yield, decreased production costs, a reduction of at least 50% in insecticide applications resulting in substantial environmental and health benefits to small producers, and significant economic and social benefits. In a recent study at Indian Institute of Management (Ahmedabad), Gandhi and Namboodiri (2006) observed that cotton farmers in major cotton-growing states such as Gujarat, Maharashtra, Andhra Pradesh and Tamil Nadu were benefited significantly. On a global basis, the benefits from the deployment of Bt cotton between 1998 and 2001 were estimated to be $1.7 billion. Surveys conducted among small resource-poor farmers in developing countries, mainly in China and South Africa, revealed that Bt cotton contributed to reduction in poverty by increasing incomes of small farmers.

 

6.4 The environmental benefits of cultivating pest-resistant transgenic crops are more profound and invisible. These are enumerated below:

Reduction in use of pesticides: The estimated total savings of insecticides on Bt cotton in 2001 was of the order of 10,627 MT, which is equivalent to 13% of the 81,200 MT of all insecticides used on cotton globally in 2001.

Fewer insecticides in aquifers and the environment: The substantial decrease in insecticides associated with the cultivation of Bt cotton has led to significant decrease in insecticide run off into watersheds, aquifers, soils and generally into the environment. More widespread global cultivation of Bt-cotton will further improve the water quality.

Reduced farmer exposure to insecticides and improvement of human health: Substitution of the chemical insecticides with Bt cotton has clearly reduced the risks to farm workers and to others in the farm community who may be exposed to the former's toxicity. These effects are particularly important in developing countries where modern application techniques are neither always adopted nor available for use.

Increased populations of beneficial insects: The global use of broad spectrum insecticides on cotton has adversely affected and decreased the populations of non-target species including the arthropod natural enemies that can provide effective control of non-lepidopteran pests. Various studies confirmed that the arthropod natural enemy populations in Bt cotton are greater than in non-Bt cotton. In addition to reducing the number of sprays for the bollworm/budworm complex, Bt cotton has also reduced the number of sprays for other insects such as thrips and aphids. This effect has been attributed to higher populations of beneficial predators and parasitic insects that are eliminated by insecticide sprays.

Reduced risk for wildlife: Reduction in the use of insecticides, many of which are highly toxic to wildlife will reduce the risks to mammals, birds, bees, fish and other organisms. Many birds are dependent on insects for food and their elimination through the use of insecticides deprives birds of their food source.

Reduced fuel and raw material consumption and decreased pollution: Lowering the demand for insecticides through the use of Bt cotton reduces tractor fuel usage as a result of reduction in number of sprays, which in turn reduces air pollution. For example, in the Hebei Province of China, where adoption of Bt cotton increased dramatically from its introduction in 1997 to 97% in 2001, farmers have noticed a substantial improvement from the chronic air, soil and water pollution levels prior to the introduction of Bt cotton in 1997, caused by the intensive spraying of cotton with insecticides.

 

6.5 What is being done about the potential risks?

Insect-resistant crops:

• Kill specific pests known to threaten the crop. In addition to their intended deadly effects, they are also:

 

Long-term exposure to pollen from GM maize that expresses the Bacillus thuringiensis (Bt) toxin has been found to cause adverse effects on the behavior  and survival of the monarch butterfly, the best-known of all North American butterflies. Effects on European butterflies are virtually unknown, as few studies have been conducted. Those few do, however, suggest cause for concern that European butterflies would suffer as a result of insect resistant GM crop being planted.

 

• Toxic to other, beneficial insects.

Genetically engineered Bt crops adversely affect insects that are important in the natural control of maize pests, such as green lacewings. In the EU (as elsewhere), environmental risk assessment for Bt crops considers direct acute toxicity alone, and not effects on organisms higher up the food chain. These effects can be important. The toxic effects of Bt crops on lacewings were via the prey that they ate. The 'single-tier' risk assessment approach has been widely criticised, with scientists suggesting that the effects of Bt crops need to be studied at multiple levels of the food web.

• A threat to soil ecosystems.

Many Bt crops secrete the toxin from the root into the soil. Residues left in the field contain the active Bt toxin. The long-term, cumulative effects of growing Bt maize have not been considered in a European context, even though this is required under EU law (Directive 2001/18). In addition to the above, risk assessments to date have failed to foresee at least two other impacts of Bt maize:
Agricultural wastes from Bt maize have been identified entering water courses, where the Bt toxin might be toxic to certain insects.  This demonstrates the complexity of interactions in the natural environment and underlines the shortcomings of the risk assessment.
Bt maize is more susceptible to a plant lice (aphid) than conventional maize, caused by changes in sap chemistry. These changes have not been described in a single application to market Bt maize but have important ecological implications. This demonstrates that plant insect interactions are too complex to be assessed by the risk assessment.

• Herbicide tolerant (HT) crops are associated with:

Toxic effects of herbicides on ecosystems. Roundup, the herbicide sold by Monsanto in conjunction with its Roundup Ready GM crops, has been shown to be a potential endocrine disrupter, i.e., could interfere with hormones.  It is also toxic disrupter, i.e., could interfere with hormones.  It is also toxic to frog larvae(tadpoles).

Increased weed tolerance to herbicide. Evolution of weed resistance to Roundup is now a serious problem in the US and Ready crops are grown on a large scale. Increasing amounts of herbicide have to be used to control these weeds or else additional herbicides have to be used to supplement Roundup.

Loss of weeds and other biodiversity. A UK government study found there were 24 % fewer butterflies in the margins of GM oil-seed rape (canola) fields, because there were fewer weed flowers (and hence nectar) for them to feed on. In addition, there were fewer seeds for birds from oil-seed rape and sugar beet.  HT maize only compared favourably (in terms of impacts on biodiversity) to maize treated with the herbicide atrazine, which is now banned in the EU. Reduction in soil bacteria. The use of herbicides on GM soy leads to reduced amounts of beneficial nitrogen-fixing bacteria.

 

7.0 FUTURE OF GM CROPS IN INDIA AND THE WORLD

Genetically modified crop technology has revolutionized agriculture in the United States, Canada, China, and Argentina. It exhibits the potential to have much wider impact, solving many of the current problems in agriculture worldwide. The types of GM crops that may become available in the future could boost crop yields while enhancing the nutritional value of staple foods and eliminating the need for inputs that could be harmful to the environment. While the environmental, health, and economic risks of GM crops should be carefully studied before full­scale adoption, the types of GM crops that are already available have thus far largely proven to be beneficial to agriculture and even to the environment, without evidence of adverse health or environmental impactsIn 2002, 58.7 million hectares of GM crops were grown worldwide with two thirds in the US. Others countries growing GM crops are Argentina, Australia, Bulgaria, Canada, China, Columbia, Honduras, India, Indonesia, Mexico, Romania, South Africa, Spain and Uruguay. Globally, nearly 12 million hectares of GM maize were grown in 2002.In the US, around 25% of the maize harvest is genetically modified. In Europe, commercial growing of GM Bt maize is already underway in Spain. Around 70% of the US soya planted is GM. In Argentina the figure is 95%. Currently, around 46% of the entire global soya crop is GM. Yet, in other than the four countries mentioned above, the GM crop movement has had little or no impact. In those parts of the developing world where an agricultural revolution might be most welcome, the Gene Revolution has yet to be embraced. Why is this so? For one thing, the Gene Revolution began in a different way than the Green Revolution. GM crops were first created within the context of the biotechnology industry to provide enhanced agricultural technologies to the industry's primary customersfarmers in the industrial world. These crops were not meant at the outset to be a life­saving technology for the developing world. Although it is almost certainly possible from a scientific and technological standpoint to create GM crops that would be beneficial to developing­world farmers, neither producers (the biotech industry) nor consumers (developing world farmers) have sufficient economic incentives for this to happen. In fact, the enormous costs of \producing each GM crop variety could prove to be a disincentive for the industry to develop "orphan GM crops" that would benefit developing world farmers. Additionally, even if the biotech industry were to develop GM crops that are beneficial to farmers in the developing world, the poorest of those farmers would not be able to afford GM crop seed instead of conventional varieties, much less purchase new GM crop seed for every planting season, as biotech patents would require them to do. Finally, the current political situation is not as conducive to promoting this new agricultural movement as it was for the Green Revolution. For all the potential that GM technology holds, there are many challenges to be overcome if GM crops are to truly introduce a "Gene Revolution" worldwide. In future the following goals need to be met and their related challenges overcome.

 

8.0 GM CROPS: THE GLOBAL ECONOMIC AND ENVIRONMENTAL IMPACT

This study presents the findings of research into the global economic and environmental impact of genetically modified (GM) crops since their commercial introduction in 1996. Several studies have investigated the economic and environmental perspectives of GM crops, but these have usually been limited by trait, country, and/or year. This study therefore aims to quantify these impacts cumulatively for the period 1996-2004 through a combination of collating and extrapolating economic analysis findings from past studies and undertaking new environmental impact analysis. This global cumulative analysis over a nine-year period will better identify consistent trends in the technology impact over time as well as identify salient differences in impact between crops, traits, and countries.

The economic impact analysis concentrates on farm income effects, because this is a primary driver of adoption amongst farmers and is an area for which much analysis has been undertaken. The environmental impact analysis focuses on changes in the use of insecticides and herbicides with GM crops and the resulting impact on the environmental load from crop production. Previous investigations have been limited to an examination of changes in pesticide volumes with GM crops, whereas this study expands the analysis and includes a more robust assessment of the specific pesticide products used in different production systems and their environmental load impact. Lastly, we investigate for the first time the contribution of GM crops towards reducing global greenhouse gas (GHG) emissions because of the importance of this issue to the global environment.

 

9.0 LABELING OF GM FOOD

A major constraint in implementing the GM labelling regime in India is shortage of laboratories equipped to test food products for GM ingredients. There are just a handful of them, like the Central Food Technological Research Institute (CFTRI) at Mysore, Centre for DNA Fingerprinting and Diagnostics at Hyderabad and the National Bureau of Plant and Genetic Resources in Delhi.

A senior official with the department of consumer affairs says upgrading lab facilities will be considered once the practice is established.
Scientists add that DNA-based methods for testing genetic modification are expensive and tedious, requiring highly skilled, trained personnel. Scientists at CFTRI-Mysore say that every company is developing its own genetically modified crop with different genes because of which there is no universal and precise method to detect GMOs. For example, in herbicide tolerant soy (GM soy), two different genes confer resistance to glyphosate and glufosinate, commonly used herbicides.

So, for genetic testing of soy, scientists need to set up different protocols and optimise and standardise procedures for identifying promoter genes that regulate the expression of neighbouring genes. Thus, testing for GMOs needs to be on case-to-case basis. Scientists also enumerate difficulties in obtaining samples of crops like GM soy seed or seed powder from which DNA is to be extracted. These are required to ascertain whether the testing procedure is correct. Effective and efficient sampling plans are needed to get the most representative sample.
The procedure for importing samples of modified and unmodified crops or food stuffs requires clearances from various ministries, beginning with application to the Institutional Biosafety Committee. Once this approval is granted, an import licence and approval is required from the Directorate of Plant Protection, Quarantine and Storage under the agriculture ministry. After this, the developer firm has to be approached for seed and leaf powders-and the firm can easily turn down the request. A German company, FLUKA, supplies "certified reference materials" of a few GM crops, but at a high cost of Rs 6,000 to Rs 8,000 per gram.

Scientists add that in processed food, DNA degradation is very common, and therefore the methodology has to be modified and optimised by simulating processing operations, such as baking and autoclaving.
The absence of a sound regulatory and enforcement regime means consumers may not really have a choice over what they eat even after the new labelling rule comes into force. Ref -Down to earth 15th Dec, 2012

An innovative technology platform for translation research on transgenic crops - a department of biotechnology, Govt. of India initiative
Agriculture Biotechnology has been the priority area of research in India. According to data with regulatory agencies, 24 universities, 37 research institutions and 45 private sector companies are working on plant transgenics in about 30 crops involving a dozen of genes for traits related to resistance/tolerance to fungal/bacterial/viral diseases; insects; drought, salinity and alkalinity and herbicide; nutritional factors (Fe, carotene, protein, amino acids); hybrid production etc. however, some of the major bottlenecks in successful transfer of this technology from lab to land revolve around the delays in transferring the products of genetic engineering to the farmers fields or "commercialization".

To fill this interface between lab and land, Department of Biotechnology, has set up an innovative Technology Platform for Translational Research on Transgenic Crops (PTTC) at International Crops Research Institute for Semi-arid Tropies (ICRISAT), Hyderabad. The platform leverages ICRISAT's existing excellence in the areas of transgenic research on crop plants, molecular plant sciences and plant breeding to improve its ability to enhance the delivery of transgenic crops in agriculture. The main mission of this platform is to "translate transgenic technology and harness its products to meet the needs of agricultural growth".

The PTTC is being proposed as an initiative to blend green revolution with gene revolution to enhance agricultural productivity in a sustainable manner. PTTC can be viewed as a "clearing" house for innovative ideas and technologies in plant genetic engineering that could positively impact Indian agriculture, with the objective of providing expertise and facilities for the production and assessment of transgenic plants.
These "evolved" technologies could then be transferred to the private or public sector for advancement to the farmers.

 

10.0 Mission for Development of Transgenic crops
Translate transgenic science and technology and harness its products to meet the needs of agricultural growth.

Objectives
Platform for Translational Research on Transgenic Crops (PTTC) will function with the following major objectives:

• To develop and deploy state-of-the-art infrastructure to conduct transgenic research
• To act as a clearinghouse for technology inputs, transgenic research leads/ prototypes with proof of concept derived from Indian research institutes, universities, and other likely sources.
• To evaluate specific concepts, ideas and technologies, and advance the promising transgenic events through a development cycle with adequate safety assessments.
• To “evolve” the technology to a point where a practical application can be demonstrated, and transfer this “evolved” technology for product development and distribution to appropriate agencies.

Principles

• Create and charter an entity with express purpose of “translating” genetic engineering research into a practical, value adding technology.
• The entity would embody the requisite scientific and business skills that are appropriately balanced.

Network
To maximize the benefits of research expertise and synergies, PTTC operates and collaborates with a larger research community beyond the boundaries of a single institution. This is being facilitated and established based on ‘Hub and Spokes’ model, wherein PTTC serves as the locus for the basic infrastructure for research, training and outreach activities, and the setting up of a series of specialized satellite centers (SSCs) in each region that has the necessary experimental expertise, equipment and facilities.

Approach
Under the PTTC, priority crops for India are being identified using a well-coordinated approach through networking among various research institutions, the industry and the government. This is to ensure that the appropriate gene constructs, regeneration, and transformation technologies are identified to make the research more efficient, focused, sustainable and result-oriented. The PTTC serves as a facility of reference to strengthen national, regional and international linkages and collaborations in transgenic research and development, exchange of materials and information, and to support training, consultation and technology commercialization.

Strengths
PTTC features state-of-the-art facilities for transgenic crop development on an area of 50,000 Sq. Ft comprising the following:

• ™High-throughput transformation facility
• ™Molecular biology laboratory
• ™Analytical laboratory
• ™Plant Pathology & virology laboratory

Major activities

• Create specific projects with defined milestones and their effective management
• Contract research to develop transgenic events in crops based on proof of concept from public and private sectors
• Genotypic and phenotypic evaluation of trait-specific transgenic events of agriculturally important crops produced by public and private sector institutes, under contained greenhouse and field conditions
• Introgression of commercially viable transgenic events into agronomically acceptable varieties
• Conduct of multi-location and large-scale field trials in collaboration with institutions under the Indian Council for Agricultural Research (ICAR)
• Detailed examination of issues linked to IPR associated with the transgenic events selected for product development
• Development of biosafety dossiers for the commercialization of products based on the selected transgenic events
• Coordination and conduct thorough evaluations of the transgenic events for possible food, feed and environmental safety studies with external agencies such as the Indian Council of Medical Research (ICMR), SAUs, etc.
• Obtaining permission for growing cultivars derived from transgenic events in open fields following guidelines of the Department of Biotechnology and other regulatory agencies

Services
Complementing the core activity, PTTC will also leverage its capacities in the form of services to assist public sector research organizations and private companies, particularly Small & Medium Scale Enterprises (SMEs). Various services offered at PTTC include

 

         

 

Communication & Outreach
PTTC recognizes the importance of communication in disseminating scientific information, developments and facts to various stakeholders and hence has established a comprehensive communication strategy. As a part of the strategy, PTTC will organize various capacity building programs, workshops, conferences /symposiums, press releases, publications, handouts, and a website.

Outcomes
PTTC will contribute greatly to the advances in the development and deployment of transgenic crops, and will continue to have a growing role in developing global public goods that can benefit the poor. Besides, PTTC can contribute vastly towards:

• Developing global capacities
• Enhancing collaborations/partnerships
• Model replication
• Resource augmentation

PTTC would serve as the locus for the basic infrastructure for research, training and outreach activities, with setting up a series of specialized centres which will serve as centers for transfer of proven technologies and also leverage convergence between various fields of related disciplines and provide support in priority areas of transgenic research.

 

11.0 GENETIC ENGINEERING APPROVAL COMMITTEE (GEAC), GOVT. OF INDIA

The Ministry under the Environment Protection Act (1986), has notified the "Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989" (known as Rules, 1989). The Genetic Engineering Approval Committee, the apex body under the Rules, 1989 has the mandate to approve the large scale trials and commercial release of Living Modified Organisms (LMOs) and ensure that research and development and testing of LMOs prior to release are conducted in a safe and scientific manner. The rules also cover the application of hazardous microorganisms which may not be genetically modified. Hazardous microorganisms include those which are pathogenic to animals as well as plants. Seven meetings of the Genetic Engineering Approval Committee have been held from April, 2007 till date.

 

11.1 Activities Undertaken by GEAC:
Commercial Release of transgenic Crops
The Bt technology was deployed in cotton crop through genetic engineering techniques for control of bollworms the major pest thereby reducing the risk of crop failures and use of pesticides. Bt cotton producing a natural insecticide that comes from the ubiquitous soil bacterium known as Bacillus Thuringiensis was approved by the Genetic Engineering Approval Committee (GEAC) for introduction in India in 2002 after extensive biosafety and agronomic testing. As of date, the GEAC has approved 1 35 Bt cotton hybrids expressing Cry 1 Ac gene (MON 531 event) and stacked genes Cry 1 Ac and Cry 2Ab (MON 15985 event)-BG-II developed by M/s Mahyco, encoding fusion genes (cry  1Ab+Cry Ac) 'GFM developed by M/s Nath Seeds and cry 1 Ac gene (Event-1) developed by Mis J. K. Agrigenetics Ltd of which 73 Bt cotton hybrids were approved for commercial release in the nine cotton growing states namely Andhra Pradesh, Gujarat, Haryana, Karnataka, Madhya Pradesh, Maharashtra, Punjab, Rajasthan and Tamil Nadu.

 

11.2 Accrued benefits of Bt technology in cotton crop include
The total acreage under Bt cotton has increased from 72000 acres in 2002 to 128,44,000 acres (approximately 5.2 million ha) in 2007.
The productivity per unit ha has increased from 300 kg in 2002-03 to 520 kg in 2006. As per the Cotton Advisory Board this is expected to increase more than 560 kg per ha.

The cotton production has increased from 13.6 million bales in 2002 to 28.0 million bales in 2006. As per the Cotton Advisory Board estimates the production is expected to increase 31 million bales in 2007
During Kharif, 2006, the area, the overall cotton production is up by 3835 K quintals of seed cotton or 788K bales of lint.

 

Bt cotton reduced pesticide usage by 2260 MT of pesticides.
India was a major importer of cotton till 2003. With the introduction of Bt technology India has become a major exporter. The export of cotton has increased from 0.9 million bales in 2005 to 4.7 million bales in 2006. As per the Cotton Advisory Board, the export is expected to increase to 5.5 million bales in 2007.

 

Transgenic Bt Brinjal developed by M/s Aahyco-First GM Food crop
The Bt brinjal developed by M/s Mahyco expressing cry 1 Ac gene from Bacillus thuringiensis tolerant to the fruit and shoot borer is the first GM food crop under advanced stage of field testing. The GEAC has approved the large scale field trials of St brinjal in the research farms of Indian Institute of Vegetable Research/State Agricultural Universities/ Indian Council of Agriculture Research based on the recommendations of the Expert Committee on Bt brinjal constituted by the MoEF.

 

11.3 Regulation of GM Crops in India
The National Biotechnology Board, which was constituted in 1982 issued a set of biotechnology safety guidelines in 1983 to undertake biotech research in laboratory and contained use settings. In 1986, the National Biotechnology Board was promoted to a full fledge Department of Biotechnology (DBT) under the Ministry of Science and Technology (MOST).  In the early years, DBT monitored developments in the biotech field globally, developed safety guidelines and made efforts to promote large-scale use of indigenously relevant biotechnologies in the country. Realizing the importance of adequately assessing biosafety, biodiversity and environmental risks, the research, product   velopment and commercial release involving GMOs, hazardous microorganisms and trans-boundary movement of the living modified organisms (LMOs) by default were reallocated to MOEF. The  overnment of India (Allocation of Business) Rules 1961 assigned the responsibilities of ‘biodiversity conservation’ and ‘environment protection’ to MOEF in 1961 (Government of India, 1961). 
Thereafter, MOEF began regulating genetically modified organisms and products thereof under the existing Environmental Protection Act 1986, commonly referred as EPA 1986, which was enacted by the Parliament of India in 1986. Whereas the EPA 1986 does not describe GMOs and GM crops in the law per se, it lays down the legislative provisions to regulate ‘hazardous substances’  and to make administrative rules to regulate environmental pollution caused by hazardous substances. Henceforth, MOEF drafted and notified ‘the rules for the manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells in 1989’ referred as the EPA Rules 1989 under ‘hazardous substances’ section of the EPA 1986. As a result, GM crops, GMOs and the products of genetic engineering were de facto categorized as ‘inherently harmful’ in the same manner as hazardous substances that cause harm to human beings or other living creatures, property or the environment. Notably, the EPA Rules 1989 to regulate GMOs and GM crops were issued by an ‘administrative order’ through publication in the Gazette of India vide notification GSR 1037(E) dated 5 December 1989 and came into force vide notification S.O.677(E) dated 13 September 1993 (Gazette of India, 1989, 1993). The EPA Rules 1989 cover a range of activities involving manufacture, use, import, export, storage and research of all genetically engineered organisms including microorganisms, plants and animals and products thereof. The Rules also apply to hazardous microorganisms that are pathogenic to human beings, animals or plants, regardless whether they are genetically modified. The Rules 1989 not only regulate research, development and large-scale commercialization of GM crops but also order compliance of the safeguard through regulatory approach, post-approval monitoring of violation and non-compliance . The Rules define competent authorities and composition of such authorities for handling of various aspects of GMOs. There are six competent authorities that function into a three-tier system; the first tier includes the ‘Policy Advisory Committee’ such as the Recombinant DNA Advisory Committee (RDAC); the second tier consists of ‘Regulating and Approval Committees’ such as the Institutional Biosafety Committee (IBSC), the Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC), and finally, the third tier includes the ‘Post Monitoring Committee’ comprising of the State Biotechnology Coordination Committee (SBCC) and the District Level Committee (DLC). The functions of each of the committees have been articulated in the Rules 1989. In the spirit of interministerial coordination, the implementation of the Rules 1989 was fast tracked with the subject matter experience and expertise of DBT. As a matter of fact, the EPA Rules 1989 assigned the biosafety, risk assessment and risk management related aspects of GM crops to DBT. Notably, DBT was made an integral part of the EPA Rules 1989, which was a unique feature allowing both ministries – MOEF and DBT of MOST – to regulate and safeguard from any foreseeable harm and weigh risks and benefits of GM crops and hazardous microorganisms under the Rules 1989. However, in case of post-monitoring of GM crops, the EPA Rules assigned the responsibility to the respective State (s). It established a regulatory framework involving multiple government departments and delineated the administrative structure, authority, procedure and requirements for the regulation of GM crops at Union and States level. However, the Rules 1989 were unclear on the role and responsibility of the Ministry of Health and the Ministry of Agriculture – the important ministries that are empowered to regulate seed and human health and matters related to regulation of GM crops. Over the years, the biosafety regulatory system has evolved into a dynamic and comprehensive regulatory framework that involves different ministries; first, the ministries authorized under the EPA Rules 1989 and second, the ministries that indirectly deal with GM crops. Figure 6 describes the interministerial coordinated regulatory framework on GM crops in India.
The regulation of GM crops from development, environmental release to commercial approval has been covered by three legislative Acts enacted by the Parliament of India and administered by different ministries. These included the Environment Protection Act 1986 implemented by MOEF, the Seed Act 1966 & the Seeds (Control) Order by Ministry of Agriculture (MOA) and the Food Safety and Standard Act 2006 (subsumed the Prevention of Food Adulteration Act 1954) by the Ministry of Health and Family Welfare (MOH&FW). 

The EPA Rules 1989 were made central to the biosafety regulation of GM crops whereas others applied to food safety and quality of seeds for sale and matters connected there to (Asia Law House, 2005). The next layer of legislations (secondary legislation) dealt with import of material for R&D, access to biological resources and intellectual protection of plant varieties. Each Act has been implemented through a detailed guideline termed as Rules that described function, process, power and composition of different regulating agencies to implement the Act. As per the EPA Rules 1989, the Recombinant DNA Advisory Committee (RDAC) set up by DBT brought out a first set of ‘Recombinant DNA Safety Guidelines’ in 1990 to regulate Rdna technology in medicine and agriculture. These guidelines were revised in 1994 as ‘Revised Guidelines for Safety of Biotechnology’. Realizing the need for comprehensive guidelines for transgenic plants in the mid-nineties, DBT framed and released a comprehensive guide for GM crops in 1998 referred to as ‘Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts’ to regulate GM crops and products. With regard to the application of GM crops, the guidelines 1990, 1994 and 1998 outline safety procedures, testing and use of genetically modified organisms and products. Considering the ecological consequences and the potential risks associated with the environmental release of GM crops, the guidelines prescribe the biosafety evaluation and risk assessment of the environmental aspects and agronomic performance on a case-by-case basis taking into consideration specific crop, trait and agro-ecological system. These guidelines also call for regulatory measures to ensure safety of imported GM materials in the country . 

The regulatory system evolved along with the import of transgenic crops, GM mustard by Proagro and Bt cotton by Mahyco for R&D purpose in the mid-nineties. The development of GM mustard Brassica juncea was discontinued in 2001 by Bayer CropScience that acquired Proagro at the penultimate stage of commercial approval. The insect-resistant Bt cotton varieties primarily Gossypium hirsutum developed by Mahyco in collaboration with Monsanto received approval for commercial cultivation in 2002. The approval process witnessed an intense debate and protest as a result of the evolving nature of regulatory system responding to scientific, technological, policy and social chal-lenges. After gaining a considerable field-level experience with BG-I© Bt cotton event, GEAC approved three new cotton events in 2006 namely BG-II© Bt cotton expressing Cry1Ac and Cry2Ab developed by Mahyco, Event-1 Bt cotton expressing Cry1Ac developed by JK Seeds and GFM event expressing Cry1Ab and Cry1A developed by Nath Seeds. Subsequently, two more events namely BNLA-601 expressing Cry1Ac developed by UAS, Dharwad and MLS-9124 expressing Cry1c developed by Metahelix Life Sciences in 2008 and 2009, respectively. In the meantime, the regulatory agencies processed the hybrid-based regulatory approval of Bt cotton, a more cumbersome and time consuming process to the event-based approval mechanism (EBAM) in 2009.  This system allowed regulators to closely evaluate, monitor and assess risk and benefits of other GM crops including Bt brinjal, Bt/HT maize, Bt/HT cotton, Bt cauliflower, Bt rice and GM mustard that were extensively field tested in the country. The GEAC in the 97th meeting held on 14th October 2009 concluded that Bt brinjal event EE-1 is safe for environmental release. However, GEAC referred the decision to approve or reject the environmental release of Bt brinjal to MOEF (GEAC, 2009a). Bt brinjal event EE-1 was developed indigenously by Mahyco in collaboration with the University of Agricultural Sciences Dharwad, the Tamil Nadu Agricultural University Coimbatore and the Indian Institute of Vegetable Research Varanasi. The project was subjected to a rigorous and stringent regulatory approval process strictly complying with twodozen regulatory permits issued by RCGM and GEAC between 2000 and 2009. On farm-level conditions, Bt brinjal demonstrated an effective resistance to the deadly fruit and shoot borer Leucinodes orbonalis that required sprays twice a week resulting in 15–40 insecticide sprays or more in one season and caused significant losses of up to 60–70% in commercial plantings. In spite of that, MOEF decided to impose a moratorium on the commercial release of Bt brinjal on 9th February 2010 pre-empting long-term health risk and liability relating to loss of biodiversity (MOEF, 2010).

 

Figure- 4: Interministerial coordinated regulatory framework on GM crops in India.

11.4 Cartagena Biosafety Protocol

The Cartagena Protocol on Biosafety, the first international regulatory framework for safe transfer, handling and use of living Modified Organisms (LMOs) was negotiated under the aegis of the Convention on Biological Diversity (CBD). The Protocol was adopted on 29th January, 2000. One hundred and forty three countries have signed the Protocol. India has acceded to the Bi6safety Protocol on 17th January 2003. The Protocol has come into force on 11th September, 2003. As of date, 143 countries are Parties to the Protocol. (Table – 2)

 

Table – 2: Transboundary Movements of Genetically Modified Organisms and the Cartagena Protocol: Key Issues and Concerns

The following points should keep in consideration for implementation of GM crops:

• Donors and governments should address the wider causes of food insecurity - land, credit, agricultural training and infrastructure - before putting resources into GM crops.
• They should introduce a moratorium on the further commercialization of GM crops until more research has been carried out into the socio-economic, environmental and biodiversity impacts of GM crops, particularly in developing countries.
• Poorer farmers and communities should be enabled to participate more in national GM debates and policy-making.
• Genetic resources for food and agriculture should be exempt from intellectual property requirements.
• Farmers' rights to save and exchange seeds should be recognized under the intellectual property rules of the World Trade Organization (WTO) and should be protected in developing country intellectual property rights legislation.
• Governments should introduce competition rules to prevent private sector monopolies and effective institutions to enforce them.
• The potential impact of GM crops on food security, poor farmers and biodiversity should guide the development and implementation of national biosafety frameworks.
• Funding for public sector agricultural research should be increased and should specialize in support for sustainable, farmerled agriculture.

(Executive summary of GM crops - going against the grain, produced by ActionAid. Visit: www.actionaid.org/)

11.5 GMO Golden Rice in Asia with Enhanced Vitamin A Benefits for Consumers
Golden Rice is genetically modified to provide beta-carotene in the rice grain and it could potentially address widespread Vitamin A deficiency in poor countries where rice is a staple. Political opponents have viewed Golden Rice as representing the interests of multi-nationals and as inherently unsafe for consumption. Progress has been made towards adapting this crop to tropical-rice growing environments, but it has not yet been introduced into farmers fields. Efficacy and safety have not yet been fully tested. Substantial work remains to target and deliver this intervention to Vitamin A-deficient populations, and to overcome remaining resistance to this technology. The political response to the on-going development of Golden Rice is reviewed to draw lessons for biofortification efforts that employ modern biotechnology. Within Asian countries, successful development and delivery will require policy dialogue among agriculturalists, health specialists, and advocates for the poor.(Table – 3)

Table – 3: Current Indian field trials of GM Crops (containing new genes/events: 2013)

 http://www.agbioforum.org

11.6 Organic vs GM food 
Genetically modified food, (GM Foods) involve controversial DNA modifications of food crop plants for purposes of adding defenses against insects or resistance to heavy applications of pesticides. The purported benefits of recombinant DNA techniques have been deemed questionable at best, fraught with negative side effects, as there are lots of studies that indicate the compounded effects of including G.E. foods in one’s diet are indeed negative and unhealthy.
Generally, it only takes a bit of research in order to understand the harmful effects of G.E. foods and that they have no place in a healthy diet. Reputed dangers of GMO foods include such things as reduced nutrition, interior toxins, birth defects and shorter life spans, increased food allergies, resurgence of infectious diseases, antibiotic threat, super viruses, viral and bacterial illness, infertility and high infant mortality rates in animals fed GM, cancer and degenerative diseases, near-deaths and food allergy reactions, even recorded GM-related deaths.
On the other hand, organically grown foods such as fruit, vegetables, nuts, seeds and meats,  are generally recognized as being superior in the nutrition they provide. These beneficial nutrients include antioxidants, vitamins, minerals, enzymes and amino acids. Organic foods are minimally processed and do not contain any hormones, antibiotics, sweeteners, food colors, or flavorings that were not originally in the food.
The process of preparing foods through cooking, industrial processing, gassing and irradiating all destroy the nutrients in raw organic foods. It would be a shame to buy organic then over process the food through conventional cooking. This depletes and deters from the purpose of healthful food. Consider adding organic raw foods to your diet for the most health gleaned from your foods.
Increasingly these days, for a number of reasons it becomes important to seek out organic foods. Processed organic food usually contains only organic ingredients, though identifying organic can be complicated. Organic defines the manner in which food is raised. This means the use of conventional non-organic pesticide (including insecticides, fungicides, and herbicides) is excluded. However, G.E. plants can be raised organically so it is important understand the definitions, interpretations  and limitations of these words in order to seek out natural or heirloom organic plants and produce.
Here’s the easy part: Look for labels that say “100% Organic”: On single ingredient foods such as fruits and vegetables, this is a small sticker or  signage in your produce section for this seal. The word “Organic” and the seal may also appear on packages of meat, cartons of milk or eggs, cheese, and other single-ingredient foods.
In the case of multi-ingredient foods such as beverages, snacks, and other processed foods things get less clear:  In the best case,100% Organic is self defined and  may also include use of the USDA Organic seal. The use of the indicator, “Organic”, defines products that contain at least 95–99% organic ingredients (by weight) in which remaining ingredients are not available organically. These products may also display the USDA Organic seal. Foods that contain 70–94% organic ingredients bear the label, “Made With Organic Ingredients”. These products will not bear the USDA Organic seal. However, they may list up to three ingredients on the front of the packaging.  Products with less than 70% organic ingredients may only list organic ingredients on the information panel of the packaging. These products will not bear the USDA Organic seal.
When considering meat and dairy products the following label terminology is used. Do not consume meat if it does not have the following labels on it:
Natural: which indicates meat that is minimally processed, and cannot have any artificial colors, artificial flavors, preservatives, or any other artificial ingredients in it. Animals can, however, still be given antibiotics or growth enhancers.
Grass Fed  is a term to denote animals fed solely on a diet of grass or hay and have access to the outdoors. Grass fed beef has been shown to have more of the healthy omega-3 fatty acids.
Free-Range indicates animals that weren’t confined to a cage and had access to the outdoors.
No Hormones Added indicates animals were raised without the use of any added growth hormones.
With regard to fish, eat only wild fish to maintain the healthiest outcome. Livestock and fish fed GMO pose the same risks as if you have eaten GMO directly. These are the labels you need to consider:
Farm Raised (farm raised fish) can involve GMO or fed GMO feed such as G.E. corn. Avoid!
Wild Caught indicates fish that are caught in the wild. However, these fish may be GMO fish that were farmed then released: A common practice to stock rivers and bodies of water.
Wild indicates wild fish hatched and grown in natural bodies of water.

11.7 Conclusion: 
The widespread adoption of GM crops seems likely to exacerbate the underlying causes of food insecurity, leading to more hungry people, not fewer. To have a lasting impact on poverty, Action Aid believes policy makers must address the real constraints facing poor communities ¬lack of access to land, credit, resources and markets- instead of focusing on risky technologies that have no truck record in addressing hunger. Bt-crops provide an effective and environmentally safe alternative to conventional pest control methods. It is easy at present to be critical of first generation Bt-crops, as they represent simple constructs that could fail. However, with any new technology, there are likely to be problems. More importantly, tools and concepts have already emerged for making better second and third generation transgenic insecticidal crops, and this trend should continue. It is important to keep in mind that transgenic crops have the potential not only of being better from an agronomic perspective, but as they greatly reduce the need for synthetic chemical insecticides, they are much better for the environment, especially non target organisms, including the predators and parasites used in biological control.

11.8 Selected activity for further study

i) Emerging Challenges

ii) Genetically Modified (GM) Crops and Biosafety

iii) Gene campaign's advocacy actions on GMOS

iv) Genetically modified crops in India

v) International Trade in GMOs and GM products: National and Multilateral legal frameworks

vi) GMO Food