Who is watching GM crops?

AT daybreak on March 11, there was a burst of activity at Litchi Lawn, a corner plot on the sprawling campus of the Pusa Institute in Bihar’s Samastipur district. Workers were uprooting the maize growing in a small patch of land close to the office, intent on finishing their work quickly as they had been instructed. The Pusa Institute is actually the old home of the Indian Agricultural Research Institute (IARI) whose headquarters has shifted to Delhi.

The 540-square-metre maize patch, surrounded by fields of wheat, mustard and cauliflower, and on the north by the institute’s famous mango and litchi nursery, looked like any other experimental plot. But something was clearly not right. After the maize was pulled out, tractors were brought in to level the land and moong, or green gram, was planted in its place.

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What was uprooted so hastily that morning? It was genetically modified (GM) maize, an insect-resistant and herbicide-tolerant variety that had been developed by Monsanto. The American biotech giant’s Event MON 89034 and Event NK603—every cell that successfully incorporates the gene of interest represents a unique “event” and the derived transgenic line is identified by such figures—was being tested at several other locations. It is still a puzzle why the Pusa trial was uprooted in such a rush and the plot replanted so quickly without due regard for contamination of the subsequent crop.

According to a Monsanto spokesperson, the regulator, the Genetic Engineering Appraisal Committee (GEAC), had sent them a letter withdrawing permission for the trial but before the company could respond, the IARI station at Pusa, acting on orders from its headquarters, had destroyed the trial. A Pusa official told Down To Earth this was done because Bihar chief minister Nitish Kumar had told Minister of Environment and Forests Jairam Ramesh that he did not want any GM trial in his state and the latter had instructed GEAC to cancel the trial forthwith.

But in its rush to scrap the trial did IARI follow procedures with regard to destruction of GM crops? Interestingly, it was Nitish Kumar himself who raised the issue. In a letter written to Ramesh three days after the event at Litchi Lawn, the chief minister pointed out that the maize trial had been “hurriedly uprooted in an unscientific manner and without the presence of any state agriculture representative”.

He also raised concerns about other possible violations: did IARI Pusa have the required isolation distance in all directions to ensure that the pollen did not flow to other crops from the GM maize?

In any case the field trials were illegal because Bihar does not have the state biotechnology coordination committee or the district-level committee, both of which are charged with implementation of the regulations and overseeing the transgenic field trials in the states (see graphic ‘How biosafety works in India’,).


If this is the state of play with IARI, which is “the country’s premier institute for research, education and extension”, it is not difficult to imagine what is happening elsewhere. As India becomes a vast testing ground for all kinds of GM crops, which policymakers believe will usher in the second Green Revolution for the country (see chart ‘Welcome to GM country’, ), there are clear indications that regulations are being thrown overboard as private crop developers and the National Agriculture Research System (NARS) join hands on the testing of GM crops.

The problem with India is that GM crop trials are being approved at dizzying speed—at one three-hour meeting, GEAC approved 144 applications—while little is done to monitor field trials, many of which are illegal because they do not comply with requirements. Quite often, GEAC has been unaware of where the trials were being held.

The most egregious example of rules being flouted is the case of Maharashtra Hybrid Seeds Company (Mahyco), which defied the regulator and used an unapproved cotton hybrid as refugia for its third generation BG2 RRF cotton that was undergoing the second stage field tests in Maharashtra. Refugia is the prescribed area where non-GM is grown so that the pests against which the GM trait is being introduced have non-toxic plants to feed on to delay the build-up of resistance to the GM toxin. GEAC regulations stipulate that 20 per cent of the area has to be the refuge crop planted all round the field where the GM crop is undergoing tests.

What did Mahyco do? Although it had been denied permission to use non- BT Round Ready Flex (RRF) hybrids as refugia at the September 2010 meeting of GEAC because it had not been approved for environmental release, it coolly went ahead and produced the seed and used it as the refuge. But Mahyco’s explanation is that it did not flout the law; it only produced non-Bt RRF seed in greenhouse for field trial purposes, according to managing director Raju Barwale. The field trials of Mahyco’s BG2 RRF cotton are being supervised by the director of the public sector, Central Institute for Cotton Research (CICR) in Nagpur. He has been defending the company which was first issued a show cause notice by GEAC and later a warning. K R Kranthi, CICR boss, says in his defence to GEAC: If only non- BT cotton without RRF was used, “there is every possibility of the refugia getting destroyed due to spray drift or inadvertent application of Roundup.” Roundup is the brand name of a broad-spectrum herbicide produced by Monsanto which contains the active ingredient glyphosate. Incidentally, Monsanto has a 26 per cent equity holding in Mahyco.

Plant geneticist and former academic Suman Sahai emphasises that this is not just a case of Mahyco cocking a snook at GEAC; the implications of Mahyco’s use of the unauthorised refugia are far more serious for Indian agriculture. “What it means is that planting a herbicide-tolerant (HT) crop, like the new Bt-HT cotton, and using the matched herbicide (Roundup) during its cultivation will destroy all the neighbouring crops and the adjoining biodiversity. This will happen when Roundup lands on them while fields of the HT crops are being sprayed. Only plants carrying the HT gene can survive the herbicide spray.” Sahai is convenor of Gene Campaign, which works to empower local communities to retain control over their genetic resources.

However, Barwale pooh-poohs such fears despite Kranthi’s contention to the contrary before GEAC. Responding to queries from Down To Earth, Barwale says: “The fear that spray of the herbicide on such herbicide-tolerant crops will destroy adjoining crops and biodiversity are unfounded and not based on any scientific data.”

He points out that herbicide-tolerant crops, including cotton, were cultivated worldwide over 89.3 million hectares in 2010. “It is our view that BG II-RRF cotton will provide additional benefits to the large number of small and marginal farmers and the environment.”

And what do the regulators have to say about violations that activists describe as flagrant? According to GEAC co-chairperson Arjula R Reddy, the regulator is pretty much powerless to do anything (see ‘We can only withdraw permission’, ). This explains why since field trials began in this country, illegalities have abounded here. The introduction of BT cotton in 2002 was preceded by the discovery that cultivation of illicit Bt was rampant in Gujarat, grown on 4,451 hectares. The authorities showed a complete inability to deal with the situation and GEAC admitted at the time there were serious shortcomings in the regulatory system.

History is repeating itself—and with vengeance. The country is now awash in illicit HT cotton and farmers in Gujarat have been growing the crop since 2006, if not earlier. Aruna Rodrigues, leader petitioner in a public interest litigation seeking a moratorium on GM testing in the country, has been campaigning ceaselessly with GEAC to halt the spread of the illegal HT cotton. It has now spread to Madhya Pradesh and Andhra Pradesh, too. She says the matter is of enormous concern because it has serious consequences for Indian agriculture and biodiversity, but so far the regulator has been unable to stop the spread. On the other hand, GEAC has been liberal in authorising all kinds of new events, including the stacked GM maize with Bt and HT. Monsanto, in fact, has been allowed to take up seed production in 10 hectares.

Rodrigues, who has been writing to GEAC since June 2009 on the illegal HT stacked cotton, says the failure to rectify matters by the regulator citing ineffective laws is unacceptable. “If laws have not been put into place after all these years to ensure strict compliance, all plantings of GMOs should be stopped.”

But politicians like Nitish Kumar are not waiting for a stricter law to be put in place. They have already decided to say a firm no to GM testing and cultivation of any GM crop in their state.

Mullakkara Retnakaran, Kerala’s agriculture minister, says, “We cannot permit open field trials until safety issues related to human and animal health and the environment have been comprehensively evaluated. Kerala is a biodiversity hot spot and we cannot take risks.” Kerala declared itself a GM-free state last year. Madhya Pradesh too has followed suit and in a letter written to Ramesh last month Ramkrishn Kusumaria, minister for farmers’ welfare and agriculture, said it would neither allow field trials nor any open releases (see ‘States say no to GM,’).

Monsanto, meanwhile, is looking for an alternative site to the Pusa trials that were stopped. A spokesperson for the company says, “This unfortunate decision to stop the trials will be a setback for research and delay access of high-income-generating crop technologies to Indian farmers.”

Nitish Kumar begs to disagree. He says maize, which is a major crop in Bihar, is doing very well. Productivity is higher than the national average and the state turns out 1.7 million tonnes, contributing more than 60 per cent of the country’s rabi production. As for the claimed advantages of GM maize, it has no relevance for Bihar.

 

How do you propose to deal with conflict of interest in GEAC?

Around three months ago a document called Declaration of Independence was prepared. Scientists who are members of GEAC were asked to sign it. The declaration states that a scientist can take decisions independently. If a GEAC member is involved in developing crops and some valid objections are raised, he/ she should just quit. They should not wait to be asked to prove that they do not have a conflict of interest.

GEAC members have been accused of not showing any interest in biosafety concerns raised by international scientists of repute. There was no debate on the reports of Eric Giles Seralini, David Andow, etc who analysed the data provided by Mahyco on the company’s work on Bt brinjal.

This is not true. When Seralini’s paper was published a meeting of GEAC was dedicated to discuss his observations. In fact, even Andow’s papers have been discussed. However, I admit that some members have objected to such discussions. Once a GEAC member, who is a biotech scientist, asked us why we should be told by foreign scientists about the problems with our industry’s studies. Some members also believe that such reports are commissioned. But this does not deter GEAC discussions.

How does GEAC respond to the very serious health and environmental concerns raised by international scientists after seeing Mahyco data? Why did GEAC not spot them?

Most of these papers are based on reinterpretation of data rather than original research. GEAC did go through a lot of data over and over again. The data were developed as per the prescribed protocols in the last few years. There is no basic data that is convincing on damage to the environment.

How do you react to states refusing field trials of GM crops? What if more states join this resistance to GM crops?

States’ decisions are not based on just data or any scientific argument. They are based on conviction. Bihar chief minister Nitish Kumar thinks the state does not need GM crops. That is his prerogative. Similarly, another state minister has given the argument that his government wants to ban GM because it is non-vegetarian. Each state’s reason is different.

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The fact is that agriculture is a state subject and state governments have the power to decide which crops they want to commercialise. If states are not willing, there is no way GM crops can be introduced.

However, law empowers the Central government to give permission to private and public institutes for research and development of GM crops, and later allow field trials. Since the matter of GM crops is in the Supreme Court, let the apex court decide this matter as well.

All states that have objected to field tests say the same thing— there are unresolved environment issues, worries about erosion of biodiversity, and adverse effect on human health and ecology.

These statements are based on conviction and policy rather than scientific data. But GEAC’S decisions are based on scientific data.

Civil society’s objection to GM crops is a totally different issue. It is a policy matter that needs to be addressed by government.

Why is it that after Mahyco conducted serious irregularities, GEAC let the company off with just a warning? The company used an unapproved cotton hybrid as refugia— area where non-GM crop is grown.

Mahyco has responded saying it took permission for the trials from the director of the Central Institute for Cotton Research in Nagpur. GEAC has taken action accordingly. The committee only has the power to withdraw permission from the company in case of violation.

The issue will be discussed again at the GEAC meeting on May 10. Rules clearly say GEAC can penalise a company for violations.

As the company has appealed again, the final decision is yet to be taken and it would be dealt with accordingly.

Has the functioning of GEAC eroded its credibility?

It is wrong to question the credibility of scientists who are part of GEAC and Review Committee on Genetic Manipulation. Though there are some scientists who may have conflict of interest, it does not mean that all scientists are unaware of their responsibilities. There are certain duties and protocols that have to be followed within a framework. Before you point a finger at the scientist community, remember that they know what they are doing.

What is your response to civil society’s charge that there is no balanced representation in GEAC?

I feel the opposition is more because of national control of agriculture than the technology itself.

Biotechnology is just like nuclear technology. One cannot be sure what the aftereffects would be. What can you oppose? If you oppose GM crops you should also oppose use of pesticides. More and more people are dying because of pesticide use. That is why civil society has taken a stand. It is clearly on one side. How can you put them on a regulatory committee which involves complex scientific issues that have to be critically analysed?

IT is just a 12-member body but the Agricultural Group (AG) of the Association of Biotechnology Led Enterprises (ABLE-Ag) must be about the most powerful lobby groups in India. Among the dozen companies are the world’s largest biotech companies— Bayer BioScience, Dow AgroSciences, Monsanto, PHI Seeds—and a clutch of rising Indian firms, all of whom are pushing genetically modified crops in the country. So when the group was allowed to make a presentation to the apex regulator, the Genetic Engineering Appraisal Committee (GEAC), it set off a battle by different interest groups.

In a situation where regulatory regime is already riddled with conflicting interests, it is objectionable that GEAC allowed industry bodies to make a case for themselves           — KAVITA KURUGANTI, Alliance for Sustainable and Holistic Agriculture

Kavitha Kuruganti, who works on issues related to sustainable agriculture and farmers’ livelihoods, immediately shot off a letter to GEAC criticising it for allowing industry associations to lobby for unscientific and fasttrack approvals which jeopardise biosafety. “In a situation where the regulatory regime is already riddled with conflicting interests, it is objectionable that the GEAC allowed these industry bodies to make such a case for themselves,” she wrote.

As a result, the regulator has now allowed representatives of the following organisations to present their own arguments: the Centre for Sustainable Agriculture, Greenpeace India, Thanal and Kheti Virasat Mission apart from Aruna Rodrigues, the petitioner in the Supreme Court public interest litigation seeking a moratorium on testing of genetically modified organism in India. This should liven up the regulatory battle as GEAC, a staid body of about 30 scientists, bureaucrats and health experts, listens to the people’s voices on biosafety concerns.

Earlier, the National Seeds Association of India (NSAI) had also made a pitch for change in regulations. According to N K Dadlani, a director, the association’s demands were similar to that of ABLE but with two significant differences. “NSAI has objected to the working of standing committees that have been formed by GEAC because these are trying to lay their own rules. The standing committees should follow the guidelines of GEAC rather than come up with their own,” he says. The inordinate delays on their part are causing huge problems for industry. The other difference was the use of refugia. NSAI has demanded that the refugia should be planted on one side of field trials instead of all around the field.

Speaking for the big boys of the industry, Shanthu Shantharam, executive director of ABLE-Ag, told Down To Earth that it was seeking clarity in the regulations and eliminating wasteful procedures. For instance, the need to repeat overseas laboratory tests in India. “It is scientifically absurd and a complete waste of time.” Although GEAC has rejected many of ABLE-Ag’s demands and put several others on hold, the anti- GM lobby is incensed by some of the demands and has picked holes in its contentions.

While data from any lab following sound protocols can be accepted, it is important to see that GM material used is produced in the country where it is going to be released   Photo: Sayantoni Palchoudhuri         — G V RAMAJANEYULU, Centre for Sustainable Agriculture

The laboratory tests argument, according to former ICAR scientist G V Ramanjaneyulu, is not quite sound. “While the data from any lab following sound protocols can be accepted, it is important to see that the GM material (plant or animal) used should be produced in the country where it is going to be released. The expression of the plant varies with ecological situations,” points out Ramanjaneyulu, who is executive director of Hyderabad-based Centre for Sustainable Agriculture. “Certain proteins, etc, which could have detrimental effects and are not seen in temperate climatic conditions, could show up in tropical conditions.”

As for pollen flow studies, ABLEAg argued that these tests should be done away with given the prevalence of other data on this subject. GEAC’s response to this was that “only India-specific data, if available, will be accepted. In all other cases, the applicant will have to conduct pollen flow studies as part of the biosafety assessment”. This has not gone down well with those who see it as industry’s attempt to dilute regulations. “Pollen flow studies look at very specific kind of risks and the risk of contamination is very location-specific, depending on insect, wind, crop, varietal and other variables. In fact, apart from pollen flow studies, risk assessment should look at physical contamination or mixing up potential too,” says Kuruganti.

Other relaxations sought by industry could have serious repercussions, according to S Krishnaswamy, president, Tamil Nadu Science Forum. He says the Biosafety Research Level 1 and 2, the field tests of GM crops, have to be conducted at the same sites: the first for two years and Level 2 for one year. Allowing flexibility to the applicants is a risky idea, according to the professor of structural biology who has been tracking issues related to GM crops. “It is good that GEAC has not entertained ABLE’s proposal.”

However, it is ABLE-Ag’s proposals on refuge/insect resistance management that have provoked the strongest reactions. Ramanjaneyulu says the existing norms are already being violated because no refuge is being planted anywhere in the country. “Even GEAC has accepted it in its minutes. Any dilution of this will have serious repercussions,” Kuruganti, too, agrees.

“The reality is that no refuge is being maintained by any farmer out there. It is also very clear that unscientific suggestions are being put forward, including the use of pigeonpea as refuge. Tomorrow, when herbicide-tolerant crops come in and there is herbicide drift from the crop, which refuge can withstand this?” Among the curious demands is ABLE-Ag seeking protection from vandalism: “With increasing NGO activism some universities are refusing to conduct the BRL trials… in such cases the applicant should be free to approach any other university or conduct trials in farmers’ fields. In such circumstances, GEAC should treat such requests on urgent basis so that the applicant does not lose an entire season due to procedural delays.”

Kuruganti finds it interesting that GEAC talks about release of untested GM material in connection with vandalism. “This is exactly the kind of risk that civil society groups do not want this country to take and, therefore, open air trials of untested products should not be allowed at all. This is not just about vandalism but about this possibility (release of untested material) existing in all trials.”

This will be quite a dilemma for the regulator.