Genetically modified (GM) food crops and products will finally make their way out from labs to the fields of India, something quite unthinkable in November 2013. This is just the beginning, by all indications. While GM soybean and canola oil may soon be part of the Indian kitchen, the transgenic varieties of rice, wheat, brinjal, chickpea, maize, sorghum and mustard are also likely to reach our plates within three to five years. (Also read: “GEAC has ignored the right of consumers”)

Paving the way for the ‘food-grade’ GM crop in India, the country’s biotech regulator, the genetic engineering appraisal committee (GEAC), on July 18 gave its go ahead to three applications for imports of GM soybean oil. The statutory body, in its 121st meeting, also cleared the decks for confined field trials, accepting 13 requests from the 15 cases evaluated. GEAC chairman Hem Pande also announced the approval of field trials for certain varieties of GM crops including rice, brinjal, chickpea, mustard and cotton.

GEAC is the apex body constituted under the ministry of environment and forests (MoEF) to control the approval of activities involving large-scale use of hazardous micro-organisms and recombinants in research and industrial production. It is also mandated with approving the release of genetically engineered organisms and products into the environment, including experimental field trials.

The committee said it approved three applications for import of GM soybean oil on the basis of the fact that highly processed foods like oil do not contain detectable DNA or proteins. “The same was confirmed by the central food technological research institute (CFTRI), Mysore after testing of the oil samples,” it stated.

The approval came within less than two months (53 days, actually) of the new government taking over at the centre. The approvals had been held in abeyance for over two years after the then environment minister Jayanthi Natarajan put her foot down. Refusing to sign the file put forth by GEAC, Natarajan wrote to the PMO, saying the ministry cannot approve field trials of GM crops as the matter was pending with the supreme court.

The case she referred to resulted from a public interest litigation (PIL) filed by the civil society group Gene Campaign and activist Aruna Rodrigues, seeking a blanket ban on field trials. The court-appointed technical expert committee (TEC) had suggested an indefinite moratorium on trials of GM crops unless shortcomings in the regulatory process were plugged. However, committee member Dr RS Paroda had given a dissenting note on the moratorium and submitted a separate report to the court.

Conflict within
The tug-of-war between the MoEF and the rest of the UPA2 government, particularly the then agriculture minister Sharad Pawar, in turn had left the GEAC completely paralysed. It did not hold even a single meeting between April 2012 and March 2014, thereby creating a backlog of 79 applications seeking permission for field trials. These pending cases, recommended by the review committee on genetic manipulation (RCGM) under the department of biotechnology, included 37 cases of revalidation and 42 new cases that involved confined field trials for the GM varieties of cotton, rice, castor, maize, wheat, groundnut, sugarcane, chickpea, mustard, sorghum and brinjal.

However, Natarajan was not alone in her belief that the country first needs to put in place stringent regulations before it can allow agro-scientists to pursue open field research that also runs the risk of contaminating nearby non-GM crops. Her predecessor Jairam Ramesh had, in February 2010, stopped the commercial launch of Bt brinjal due to opposition from brinjal-growing states – Andhra Pradesh, Chhattisgarh, Karnataka, Bihar, West Bengal, Odisha, Uttarakhand and Madhya Pradesh – and on the ground that there was a lack of consensus among the scientist community.

Justifying the moratorium Ramesh had said that it had been imposed to allow scientific studies to establish the safety of the product from the point of view of its long-term impact on health and environment. It was during his term as the environment minister that he suggested setting up a regulatory authority for the biotechnology sector.

What changed the stance?
While the GEAC under the new NDA government has decided to turn the tables by clearing the backlog, the ball was set rolling by UPA2 itself with the removal of Natarajan. She was replaced by M Veerappa Moily to soften the MoEF’s stand on various contentious issues and to woo the industry at large ahead of the parliamentary elections. One of the first things that Moily did was to allow GEAC to get back to routine.
Moily’s go ahead on February 27 not just enabled the GEAC to quickly call a meeting on March 13 and give green signal for the field trial of 11 transgenic crops. The minister’s decision was backed by the heavyweight Pawar, a known proponent of GM crops, who had made the agriculture ministry’s pro-GMO stand very clear in the Lok Sabha.

Batting strongly in favour of the genetically engineered crops, Pawar had cited the example of Bt cotton, saying its success showed how farmers themselves opted for this crop which in 2012 had earned the country '21,000 crore from exports. “I honestly feel that the farmer of this country is wiser than me... It is not proper to say that Bt cotton is not useful,” Pawar had said, adding that farmers preferred genetically modified cotton as it gave higher yield, was more disease resistant and provided more profit.

Hitting out at the anti-GM crop groups Pawar had also said that while certain organisations based in the US were engaged in propaganda against genetically modified crops, their own country was growing such crops and even exporting them to India. “They are using, they are producing and they are exporting to us. But when we think of using these varieties here, definitely there is opposition.”

Moily’s stand was that the GEAC’s decision was not bound by the supreme court’s moratorium (on field trials) order. And though the regime and the minister had changed, five months later Pande used almost the same words to justify GEAC’s July 18 decision.

While UPA2 had prepared the ground, it is Narendra Modi’s leadership that has propelled the GM story further. During his 12 years as Gujarat chief minister, Modi not only pushed Bt cotton but also promoted the use of biotech in agriculture in general. Fully backing a modern technology that can deliver economic gains – never mind the potential pitfalls – has been the hallmark of his style of governance. He is prepared to ignore or even silence any criticism from the civil society – and curiously, even in this regard, UPA2 has prepared the ground for him with the controversial intelligence bureau (IB) report that targeted several prominent environmental activists and groups – including Greenpeace (more on that later). The result is that there has been no criticism, no opposition to the latest GEAC decision – not from the green groups. Ironically, the only criticism comes from those elements within the Hindutva fold who still swear by the Swadeshi ideology. But it is a measure of Modi’s might that even the criticism from these quarters is muted – in a sharp contrast to the Vajpayee era when the Swadeshi Jagaran Manch used to have its say.

Regulatory framework
The regulatory framework for biotech crops, animals and products in India is governed by the Environmental Protection Act of 1986 and the Rules for the Manufacture, Use/Import/Export and storage of hazardous microorganisms/Genetically Engineered Organisms (GMOs) or Cells, 1989. These rules govern research, development, large-scale use, and import of the biotech organisms and their products. The rules also identify six competent authorities responsible for reviewing, evaluating and approving GMOs in India: Genetic Engineering Appraisal Committee (GEAC), Review Committee on Genetic Manipulation (RCGM), Recombinant DNA Advisory Committee (RDAC), State Bio-safety Coordination Committees (SBCC), District Level Committees (DLC) and Institutional Bio-safety Committees (IBSC).

In 1990, the department of biotechnology (DBT), in the ministry of science and technology (MoST), developed Recombinant Deoxyribonucleic Acid (DNA) Guidelines, which were subsequently amended in 1994. In 1998, the DBT issued separate guidelines for biotech plant research, including the import and shipment of biotech plants for research use. In 2008, the GEAC adopted guidelines and standard operating procedures for the conduct of confined field trials. The GEAC also adopted new guidelines for safety assessment of foods derived from genetically engineered plants.

On November 13, 2007, the MoST unveiled a national biotechnology strategy to strengthen the regulatory framework, instituting a national biotech regulatory authority (NBRA) that would provide a single window mechanism for biosafety clearance. In 2008, the DBT issued a draft National Biotechnology Regulatory Bill, together with a draft establishment plan for setting up the NBRA. Following inter-ministerial consultations with different stakeholders, the DBT subsequently drafted a revised Biotechnology Regulatory Authority of India Bill 2012 or BRAI (see box on BRAI). The bill was introduced in parliament on April 22, 2013. However, it could not be taken ahead by the Manmohan Singh government and India continues to lack a strong mechanism for regulating the research and manufacturing of biotechnology products. Pending parliamentary approval of the BRAI, India’s regulatory mechanisms continue to be governed by the EPA 1986 and the Rules of 1989.

GM crops: Lab to field
The GEAC is ultimately responsible for approving all field trials. In 2008, GEAC adopted an ‘event based’ approval system, reviewing the efficacy of the event/trait, and focusing on biosafety, particularly on environment and health safety. Before any biotech event can be approved for commercial use, it must undergo extensive agronomic evaluation through field trials under the supervision of the Indian council of agricultural research (ICAR) or a state agriculture university (SAU) for at least two crop seasons.

Product developers can also conduct agronomic trials in conjunction with the biosafety trials, or can also do so separately after GEAC recommends environmental clearance and the government of India gives final authorisation. For approval purposes, a stacked event, even if consisting of already approved events, is essentially treated as a new event.

However, India does not have any specific regulations on co-existence between biotech and non-biotech crops. On January 10, 2007, the GEAC decided against allowing multi-location biotech field trials in basmati rice growing areas, particularly in the states of Punjab, Haryana and Uttarakhand. In early 2011, some state governments objected to approval of biotech crop field trials without state permission. On July 6, 2011, GEAC amended the procedures for field trial authorisation, which now requires the applicant (the technology developer) to obtain a no-objection certificate (NOC) from the relevant state government.

Applications that had previously received approval from GEAC are also required to get NOC from the state government before commencing the field trials. Industry sources report that only a few states like Punjab, Haryana, Gujarat and Andhra Pradesh (cotton only) have issued NOCs for biotech field trials. As a result, a number of field trials already approved by the GEAC in 2011 could not be taken further.
States such as Maharashtra, Rajasthan and Delhi NCR are in the process of developing their own approval system.

Once an event is approved for commercial use, the applicant can register and market seeds in various states according to the provisions of the National Seed Policy (NSP) 2002 and other relevant seed regulations specific to each state. Following the commercial release of a biotech crop, the ministry of agriculture, along with various state departments of agriculture, monitor field performance for three to five years.
Experts, however, point to a conflict of interest in the GEAC; members of the apex regulatory body for GMOs include developers of the technology. “There is no statutory regulatory body and so the rules can be changed according to the decision makers,” points out Neha Saigal, food and agriculture campaigner at Greenpeace India. She says the country does not have provision for public participation in approving open air field trials at various stages.

As this a risky technology, public opinion must be obtained. “The GEAC lacks transparency and it has not been putting out minutes in the public domain. In fact, as sources have informed, they have not recorded the dissent expressed by certain members on some of the approvals,” she says adding that GEAC does not have any policy directive and is just playing the role of a clearing house.

“There is a lack of vital elements to risk assessment, like long-term biosafety testing, socio-economic assessment and need assessment. Finally, there are no monitoring mechanisms and no measures for reviewing, mitigating, preventing and, if needed, revoking proposals,” Saigal says. (See interview)

The voice of dissent
It is interesting to note that while eminent agriculture scientists such as MS Swaminathan and KC Bansal, director of the national bureau of plant genetic resources, as well as Indian council of agriculture research (ICAR) director-general S Ayyappan, have for long been advocating in favour of the GM crops in India, the TEC set up by the supreme court recommended a 10-year moratorium for certain classes of GM crops. This included food crops containing the Bt gene, herbicide-tolerant (HT) crops, and crops for which India is a centre of origin or diversity, based on concerns such as health safety, socio-economic consideration, gene flow.

The debate between pro- and anti-GMO groups has raged for over 12 years now, since 2002, when Bt cotton was first introduced in India. The majority TEC report further helped amplify the voice of dissent – from civil societies, political parties and their various fronts and section of the agricultural scientists as well.

The standing committee on agriculture led by Basudeb Acharia in its 37th report on the ‘Cultivation of Genetically Modified Food Crops – Prospects and Effects’ had also expressed concerns about the lack of adequate regulatory framework for GM crops. The committee also noted that the existing framework did not provide for mandatory consultations with state governments or seek their permission to conduct open field trials. Based on the findings, the report recommended that all research and development activities on transgenic crops should be carried out only in laboratories and the ongoing field trials in all states be discontinued.

With the advent of the BJP after garnering a clear majority in the general elections, however, there has been a new twist in the tale. During the UPA regime, opposition to GM crops came from the minister of environment and forests, while the ministry of agriculture and the PMO strongly backed them. In the new government, agriculture minister Radha Mohan Singh is not very comfortable with the idea of the transgenic crops and open field trials. While the minister is said to have expressed his reservation in private conversations, the ministry has decided not to oppose it due to political compulsions.

Prakash Javadekar, minister of environment and forests, has tried to soften the impact of the GEAC decision and pacify the right-wing activist groups when he reacted to former BJP ideologue and chief of the Rashtriya Swabhiman Andolan KN Govindacharya’s tweet. While Govindacharya had tweeted that the decision was “an anti national decision #Modi ministry to promote GM crops and damage soil and agriculture #India”, Javadekar responded with a separate tweet saying: “Field trials of #GMCrops is not a Government Decision. It is a recommendation of a Committee.”

What has come as a big shocker is the fact that the major voice of dissent has come from BJP’s own quarter – Bharatiya Kisan Sangh (BKS) and Swadeshi Jagaran Manch (SJM), two Rashtriya Swayamsevak Sangh (RSS)-inspired organisations. While the two organisations did not mince words while criticising the approval for field trials of GM crops, the known voice of dissent – Greenpeace, Navdanya, Gene Campaign and majority of the NGOs – have been more or less mute, except for the few blogs or comments that have gone as part of the media stories.

Why are the NGOs quiet?
Talking about the rather sober reaction of the NGOs, Kavitha Kuruganti of Alliance for Sustainable & Holistic Agriculture (ASHA) said that she was confused with the statement made by Javadekar, who has tried to shirk the government’s responsibility by saying it was GEAC’s recommendation.

“The GEAC makes a recommendation only after a go ahead from RCGM and is deemed to be permission for open field test, provided the company gets the NOCs from state governments after which the permission letters are issued. In fact, GEAC’s recommendation is the first step in permitting trials and whatever the minister might claim, the GEAC meeting itself is a GoI decision.” She, however, skirted the question why the NGOs were not raising the issue in a big way, as in past.

According to a senior department of biotechnology official and industry sources, the recent intelligence bureau (IB) report on “concerted efforts by select foreign-funded NGOs to take down Indian development projects” seems to have pushed to the wall major NGOs, including Greenpeace. “The IB and home ministry turning the heat on NGOs named in the report, particularly organisations leading the anti-GMO campaign, seems to have helped the government buy their silence,” said an industry expert who did not wish to be named.

The IB report states that: “Five Indian activists and six NGOs (five FCRA registered) including Greenpeace are at the forefront of anti-GMO activism in India. Anti-GMO activism was initiated in 2003 by Vandana Shiva (Navdanya / FCRA; Consultant Greenpeace Australia) and was followed by Suman Sahai (Gene Campaign / FCRA; PIL in SC in 2004 and 2007). Competing with Gene Campaign, Aruna Rodrigues filed a PIL through Prashant Bhushan in 2005. From 2010 onwards Kavita Kuruganti (Alliance for sustainable and holistic agriculture or ASHA and India for safe food or IFSF) also joined the campaign.”

The report also indicates that in the last four years these four activists have received increasing support and resources from Greenpeace International, through its Indian subsidiary. “A significant portion of foreign funding for these NGOs was sourced from German donors such as Greenpeace International, EED, Bread for the World and Misereor,” the report says, adding that the manner of free-funding for these NGOs can be observed from the fact that ASHA and its IFSF are headquartered with four prominent anti-nuclear NGOs (two FCRA registered) at a single address in Katwaria Sarai in New Delhi.

Reacting to the IB report, Vandana Shiva, Aruna Rodrigues and Kavitha Kuruganti in a joint statement have raised the issue of a “foreign hand in the report”. In a joint press release they also raised the issue of India’s sovereignty, security and freedom at risk. “Is the IB being used by foreign corporations to take over India’s vital seed sector?” the release asked.

The story appeared in the August 1 to 15, 2014 issue of the magazine