NOTE: Very informative article. The irony is of course that the kind of regulatory rubber stamping that's been exposed in India is widely practised, which is why the likes of the EFSA and the FDA find themselves facing similar accusations of regulatory capture.

Incidentally, Greenpeace India reports from the final public consultation on Bt brinjal in Bangalore (Saturday), that a majority of farmers and scientists who spoke were against its approval. Environmentalists and NGOs were apparently prevented from contributing. 1,000 people attended, more outside. Greenpeace India's live coverage via Twitter: http://twitter.com/greenpeaceindia
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Challenges posed by Bt Brinjal
Manoj Mitta
The Times of India, 6 February 2010
http://timesofindia.indiatimes.com/india/Challenges-posed-by-Bt-Brinjal/articleshow/5541948.cms

*The debate over the petridish baingan is hotting up. Environment minister Jairam Ramesh's sudden recourse to public consultations, after Bt brinjal was cleared as India's first genetically modified food crop, has exposed serious regulatory lapses. TOI-Crest looks at the challenge posed by this humble vegetable ...

The cutting-edge technology of Bt brinjal has had an unintended consequence. The public outrage that followed the regulatory clearance of the first ever GM food crop has forced environment minister Jairam Ramesh to adopt an innovation in public administration. No minister has ever before crisscrossed the country to hold a series of public consultations, that too on a policy matter already approved by a statutory regulator. Ramesh has announced that he would present his findings to the prime minister shortly following the last of the seven consultation meetings due in Bangalore on February 6.

Ramesh came up with the device of public consultations on October 15, 2009, just a day after the regulator in his ministry, the Genetic Engineering Approval Committee (GEAC), had given its go-ahead to the commercial cultivation of Bt brinjal. The series of consultation meetings chaired by him, starting in Kolkata on January 13, have turned out to be as dramatic, given the manner in which pro and anti-GM lobbies sought to demonstrate not only the strength of their arguments but also their lung power.

Not surprisingly, the sharp divide over Bt brinjal has had political ramifications. Ramesh suffered the mortification of seeing two of his colleagues in the Central government, agriculture minister Sharad Pawar and science and technology minister Prithviraj Chavan, publicly criticising the ad hoc measure adopted by him despite the GEAC's clearance.

Ramesh responded by asserting that he was not bound by the GEAC's recommendations and that he was entitled to take public concerns on board.

The issue acquired greater traction as eight state governments came out against Bt brinjal, in varying forms and degrees. And those states cut across regional and political lines: Kerala, Karnataka, Andhra Pradesh, Madhya Pradesh, Chhattisgarh, Orissa, West Bengal and Bihar. While some asked for a moratorium pending further testing of the bio-safety of Bt brinjal, others rejected the very idea of letting toxic genes be inserted into food crops.

Thus, at a time when he has been grappling with the climate change debate at the global level, Ramesh has been embroiled locally in the controversy over GM crops, seven years after Bt cotton had been introduced in India by the American MNC Monsanto.

Bt brinjal was the second GM crop to be cleared by the GEAC, this one at the instance of Monsanto's Indian associate, Maharashtra Hybrid Seeds Company (Mahyco). And this is just the beginning of what could be a biotech revolution, for better or for worse, as many more crops, including cash crops, vegetables, fruits, cereals and pulses, are in the regulatory pipeline.

GM technology, in which a gene is transferred from a different species to imbibe a desirable trait, is touted as a long-term solution to the problems of pests, hunger, drought and even climate change. Though the technology warrants serious consideration, the uproar over Bt brinjal has served to highlight a trust deficit in the regulatory system created under statutory rules framed in 1989. The GEAC, headed by an additional secretary in the environment ministry, invariably a nonspecialist IAS officer, has failed to inspire confidence in its ability to regulate a high-stakes but inherently risky technology that involves tampering with nature.

If the minister was forced to announce public consultations within a day of the GEAC's muchawaited decision on Bt brinjal, it is thanks to a series of regulatory lapses that have surfaced since at least 2006, when the Supreme Court restrained it from approving any fresh field trials. Much as it was a blow to the credibility of the regulatory system, a bench headed by the then Chief Justice of India, Y K Sabharwal, felt compelled to pass such an interim injunction as the GEAC had evidently abdicated its duty to independently examine the environmental and biosafety aspects of the proposed GM crops.

In the course of a PIL filed by activist Aruna Rodrigues seeking a moratorium on GM crops, the apex court was appalled to discover that the GEAC was rubberstamping recommendations made by the Review Committee on Genetic Manipulation (RCGM), which is part of the Department of Biotechnology, an avowed promoter of GM crops. The evidence of the GEAC's cavalier attitude lay in its minutes, which showed that in a single meeting it had cleared 91 field trials across 10 food crops.

But eight months later, thanks to the vagaries of the judicial process, a bench headed by Justice Sabharwal's successor, Justice K G Balakrishnan, vacated the stay on the GEAC. This proved propitious to Mahyco's pending application for permission to initiate large-scale field trials of Bt brinjal. The GEAC promptly granted permission. That is how, after carrying out large-scale field trials for two years, Mahyco sought to clear the final regulatory hurdle in 2009 for commercial cultivation of Bt brinjal.

The GEAC's final clearance to Bt brinjal on October 14, 2009, provoked fresh questions about its capacity and will to regulate. For, the GEAC gave little indication of mending its ways after the Supreme Court had restored its powers in May 2007.

Consider the manner in which it had subverted the same Supreme Court order on the issue of transparency. Justice Balakrishnan's bench had directed that Mahyco's bio-safety dossier on Bt brinjal be posted on the GEAC's website. But all that the GEAC put out was Mahyco's analysis and conclusions. It withheld all the raw data that would have helped experts outside the GEAC to make an independent assessment of the bio-safety claims.

It took a contempt petition before the Supreme Court for the GEAC to disclose the raw data at last in August 2008, covering, among other things, a 90-day feeding study on rats. Since international experts gave adverse feedback on the raw data, the GEAC set up an expert committee under its co-chairman , Arjula Reddy, in January 2009, in a bid to allay public apprehensions.

The expert committee concluded that Bt brinjal was "safe for environmental release in India" and that its benefits "far outweigh the perceived and projected risks" . The committee's report came on October 8 and the GEAC gave its clearance six days later. And that was despite the dissent recorded by the Supreme Court's nominee to the GEAC, P M Bhargava, saying, "he is not against GM crops, but cannot support the proposal as the safety assessment in his view is not complete" .

Bhargava's view on the incompleteness of the safety assessment was vindicated by the GEAC's disclosure of another installment of raw data on the bio-safety of Bt brinjal on November 17, more than a month after it had already cleared the crop.

Since Jairam Ramesh had by then distanced himself from it in the wake of public outrage, the GEAC made a belated disclosure of the data relating to the crucial aspect of gene flows (concerning the contamination potential of Bt brinjal). It was forced by the allegations that some of the data relied upon by the expert committee had not been made public.

With friends like the GEAC, GM technology does not need enemies. Whether the benefits of Bt brinjal outweigh its risks or not, it has come under a cloud of suspicion because of the GEAC's overweening secrecy and lack of rigour. After his yatra of public consultations, Jairam Ramesh would have to be really brave to concur with the GEAC's view that Bt brinjal in its current state was safe for environmental release. In any event, he would do well to revamp the regulatory system.

Do risks exceed benefits?

THREAT TO BRINJAL DIVERSITY

Brinjal in its varied shapes and colours is said to have originated in India. Opponents of Bt brinjal, therefore, contend that genetic engineering should not be allowed in the "centre of origin" as it could lead to the loss of original varieties by transgenic cross-pollination .

Mahyco:

Its spokesperson, when contacted, brushed aside the 'centre of origin' argument saying, "The origin of cultivated brinjal is uncertain, with differing views put forward by scientists . South America and Indo-China are thought to be areas of origin. India is considered a centre of diversity."

IS THE TOXIN PUT IN BRINJAL SAFE FOR HUMAN CONSUMPTION?

Since Bt brinjal is fatal to a pest called fruit and shoot borer, some scientists question the premise that the Bt gene acts only in the alkaline environment found in the gut of insects. For, the human digestive system is acidic only in the stomach while the rest of it is alkaline. The study done by Mahyco on rats allegedly does not address possible human dangers such as cancer, infertility and kidney damage.

Counterview:

The Bt gene breaks down during digestion into common amino acids, which are part of the normal diet and are neither toxic nor allergic.

PRECAUTIONARY PRINCIPLE

Since Bt brinjal has been developed for the first time anywhere in the world, the precautionary principle requires that its clearance should have been withheld because of the uncertainty and irreversibility of its long-term implications for health and environment . Mahyco insists there is no cause for alarm over Bt Brinjal as Bt cotton, the GM crop introduced in India in 2002, "is already in our food chain" . For, about 11 lakh tons of Bt cotton oil is consumed annually by people, directly or through vanaspati. Mahyco claims, "As the Bt gene present in cotton is identical to that used in brinjal, there is a strong precedence for safety of the gene itself."

NO LABELING AND LIABILITY REGIME

Informed consumer choice requires that the introduction of Bt brinjal be put off till a mechanism of mandatory labeling is put in place. But then, how will GM food be labeled in a country where vegetables are not sold only in supermarkets? And how feasible is it to maintain the segregation from the field to the market? Worse, there is no law fixing liability in the event of contamination of non-Bt brinjal by the GM variety.