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1.Indian scientists found guilty of marketing contaminated GM cotton seeds
2.Incompetence of GM scientists and regulators exposed

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1.Indian scientists found guilty of marketing contaminated GM cotton seeds
Dinesh C Sharma 
India Today, December 14 2012
 http://indiatoday.intoday.in/story/indian-scientists-guilty-market-contaminated-gm-cotton-seeds-india-today/1/237642.html

New Delhi - In what appears to be a case of serious scientific fraud and subsequent cover up, Indian scientists have been found guilty of commercialising contaminated genetically modified(GM) cotton seeds despite knowing about contamination for several years.

The GM cotton variety in question- Bikaneri Nerma Bt or BN Bt- was developed by the Nagpur-based Central Institute for Cotton Research(CICR) of the Indian Council of Agriculture Research(ICAR).

It was commercialised in 2009 and was touted as an alternative to the GM cotton marketed by Mahyco. Two years back, Mahyco complained to ICAR that BN Bt, in fact, contained a gene developed by its partner Monsanto.

Now, an expert panel which was asked to investigate the contamination has submitted its report. The report reveals how the contamination took place and scientists at various levels tried to cover it up. The five-member panel was headed by leading biotechnologist and JNU vice-chancellor S K Sopory. 

Not only has the panel confirmed contamination with Monsanto gene, it has hinted that the contamination may not be "accidental".

"Accidental contamination would be difficult to explain," the report says citing several technical reasons. After Mahyco complained, the seeds were tested at two labs once again.

Certain tests conducted in 2004 at the National Research Centre on Plant Biotechnology, New Delhi showed it was indeed BN Bt while different batch of the same material taken to and tested at CICR in 2005 showed extensive contamination.

"Thus, assuming only accidental contamination can not explain what has happened," the report notes.

The Indian variety was originally developed at the University of Agricultural Sciences(UAS), Dharwad and then further work was carried out at CICR Nagpur. The report says the variety got contaminated at Dharwad itself, where Monsanto variety was also being field tested.

The most shocking part of the episode is the fact that scientists knew about the contamination and yet they went ahead with regulatory approvals and comercialisation of seeds.

"There were indications prior to commercial release in 2009 that BN Bt was contaminated. These were not formally brought to the attention of relevant authorities. Neither these indications were followed up appropriately by the scientist who observed them nor was any attention paid by others who came to know of them," the report has concluded.

"There seemed to extreme hurry to come up with public sector Bt cotton," it adds.

CICR director Dr Keshav Kranthi knew there was something wrong with seeds brought by his predecessor Dr B.M. Khadi from UAS in 2005 itself.

He kept silent for four years, participated in all bio-safety and other ICAR meetings, distributed seeds to farmers and even published papers in scientific journals. At UAS, the panel said, Dr Khadi and Dr I S Katageri were lax in maintaining purity of seeds.

"Dr Khadi should have been more careful, as he got the information from Dr Kranthi about the contamination in 2008," the report said.

On the role of Dr Kranti, it says: "Dr Kranthi conducted analysis which gave him enough reasons to suspect about contamination in 2005 and 2008. Although these were crucial observations, he did not give written reports to his seniors."

ICAR has been blamed for faulty planning and poor oversight of the project.

Desi Bt cotton trail

*ICAR's Bt cotton variety 'Bikaneri Nerma' was approved by regulators in 2008

*Seeds were distributed to farmers in 2009 and the variety commercialised

*It was found in 2010 that variety's performance was poor and it contained Monsanto's GM cotton gene

*ICAR set up committee to find out if the scientists have really made a distinct Bt cotton variety and how it got contaminated

*The panel has found that while an independent variety different from that of Monsanto does exist in lab, but it got contaminated in 2004-2005

*Though scientists noticed contamination in 2005, they went ahead with seed multiplication and commercialization
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2.ICAR REPORT ON BNBt Cotton EXPOSES INCOMPETENCE OF GM SCIENTISTS AND REGULATORS TO REGULATE GMOs IN INDIA
Coalition for a GM Free India, 15 December 2012

*Coalition for GM Free India demands withdrawal of Supreme Court affidavit of Ministry of Agriculture that gives clean chit to GM regulators.

New Delhi - Reacting to the Prof.Sopory Committee Report1 that investigated the Bt Bikaneri Narma case, the Coalition for a GM-Free India said that, “We congratulate the Committee for its thorough investigation which exposes one of the worst cases of scientific fraud within the Indian Council for Agriculture (ICAR) institutions. The indictment of the agricultural research establishment and the transgenic regulatory system is a shame to the country and once again points out to the wastage of taxpayers’ funds. We demand stringent action against all people involved in the affair, including senior ICAR people and retired officials, some of who have even been shielded from this enquiry.”

It expressed dismay that the ICAR seems to be protecting its errant officials; apparently the establishment waited for the retirement of a senior official before making the report public. It also observed that another senior technocrat, Dr Bansal, was repeatedly protected by the establishment even though he was the Coordinator of this project; he does not figure either in the enquiry or the report. The long delayed report dated August 2012 is now available on the ICAR website, which means it has been with the Ministry of Agriculture for the last 4 months.

PSC and TEC concerns proven right: The Coalition spokesperson added, “The report underscores and provides evidence that support the serious concerns raised both by the Parliamentary Standing Committee(PSC) report as well as the interim report of the Technical Expert Committee (TEC) of the Supreme Court, during the last few weeks, about the inability, incapability and unpreparedness of the Indian GM research establishment to deal with this risky and irreversible technology and the gross inadequacy and incompetence of the Indian GM regulatory apparatus to regulate this technology and ensure biosafety.”

Failure of GM crop regulation: A notable failure in the whole incident is that the BNBt contamination had happened prior to commercialisation but went undetected/unrecorded by the regulatory system! The committee also pointed to the conflict of interest in the developers of BNBt sitting in GEAC as regulators and approving their own product. This same regulatory mechanism with its inadequacies had cleared the Bt brinjal dossier. There was virtually no oversight, the raw data had not been even read by the GEAC, there was complete ignorance of the data and the event – again which has happened with BNBt. Clearly the GM regulatory mechanism in the country is either incapable of, or deliberately unwilling to deal with the intricacies of biosafety testing in a rigorous manner and function transparently with the highest standards of governance. “How can the country afford to do open air releases of such a risky, irreversible technology when scientists and regulators dealing with it have shown lack of competence and care compounded by absences of ethics and internal checks and balances?” asked the Coalition spokesperson.

MOA commits perjury: “It is a travesty of honest governance and ethics that the Ministry of Agriculture filed an affidavit in the Supreme Court of India (in the GMOs PIL), arguing that open air field trials were absolutely essential and the regulatory system is robust and world class, even as it had this damning report, datelined August 2012 lying with it. This amounts to perjury as the affidavit filed in 8th November, 2012 claims that, “no part of the affidavit is false and nothing material has been concealed”.” It said that the Ministry of Agriculture has completely lost its credibility, and India’s farmer livelihoods, consumers’ food safety and the country’s biodiversity is in grave danger due the unjustified promotion of GM crops at the behest of private corporate interests and some public sector agricultural scientists.

Contamination is inevitable and Supreme Court orders violated: The fact that the whole incident emerged from contamination of BNBt by the Monsanto gene, is incontrovertible evidence that contamination is inevitable and unavoidable. The Supreme Court had in its orders of 2007 clearly directed the GEAC to have zero tolerance for contamination in/through trials. This case has demonstrated that contamination did happen at that time and that no contamination testing ever happens and/or the regulator has no means to even check or detect contamination post the event. In this case contamination finally came to light only when Mahyco complained about the illegal use of Monsanto’s gene.

The Coalition feels that given the high stakes in terms of profits and control of India’s huge seed market by private corporations, the entire episode of BNBt seeds raises serious questions on how and why this blatant and easily discernible contamination occurred. At least, this being a public sector seed, the release of data from the agricultural establishment could be ensured and the failure was subjected to thorough investigation.

The Coalition is extremely concerned at the manner in which the international patent protection laws are used by multinational seed companies to prevent access to their seeds for independent research and testing and the reliance on their testing to provide clearance to GM crops without rigorous independent testing facilities being available in India.

We demand that the Ministry of Environment & Forests immediately take cognisance of this, in addition to the reports from the PSC and TEC and immediately stop all field trials and put all applications for commercialisation of GM crops under abeyance until all these issues are dealt with.

We demand that the affidavit submitted by the MoA to the Supreme Court be withdrawn. We are deeply concerned that the Agriculture Minister has written letters to Chief Ministers to permit open air field trials despite the repeated failures of the GM research and regulatory mechanisms. We demand that MoA support the many safe methodologies that are available instead of going all out to support a technology whose need and safety have been shown by independent scientists across the world to be highly debatable if not downright risky.

For more details contact:
Kavitha Kuruganti, Ph : 09393001550
Sridhar Radhakrishnan, Ph : 09995358205

Appendix

Background: The Bt cotton in question is the Bikaneri Narma (BN) Bt (variety) and the Bt NHH-44 (Bt hybrid) touted as the “first indigenous public sector-bred GM crop in India” developed by the Central Institute for Cotton Research, Nagpur (CICR) and University of Agricultural Sciences, Dharwad (UAS) along with Indian Agricultural Research Institute (IARI). It was approved by the Genetic Engineering Appraisal Committee (GEAC), the apex regulator in 2008. The developers had claimed that the event engineered into BNBt and Bt NHH 44 is a distinct event called BNLA106. After a year of commercialisation and without any explanation BNBt and Bt NHH44 were withdrawn from the market. It was found to have the event (MON531) originally patented by Monsanto, this came to light after Mahyco complained about it. The Indian Council for Agriculture Research (ICAR) was compelled to institute an enquiry to examine the matter, when it came to light that BNBt was contaminated by a gene patented by Monsanto- whether deliberately or otherwise.

The highlights of the report: The Prof.Sopory committee has strongly and unequivocally indicted the agriculture research establishment for failing on scientific, technical, institutional and ethical fronts and has stated that, “all biosafety studies and field trials conducted with BNBt and Bt NHH 44 are invalid”. This report clearly states that contamination has happened, maybe through “out-crossing or admixtures” and states that the possibility of it being accidental is remote. It has also cast doubts on other GM research taking place in the establishment using this or similar constructs.

Technical issues: The committee pointed out that the fundamental flaw on the technical front was that the whole BNBt project rested on a single event and there were no other events to carry out an event selection process. It pointed out that, “Event specific primers were not developed for BNBt” and more worryingly rearrangement of DNA was found –which raises critical questions on stability – particularly problematic in a commercialised event. Questions were raised about the characterisation of the so-called purified BNBt.

Research issues: On the research front the committee has laid bare the lack of processes and absence of due diligence within the ICAR establishment in how project proposals are written and tasks delegated and finally the project executed. The report has pointed out how the ICAR lacks capabilities on many fronts but pretends to have them; for example in this case a scientist who admitted to not having a certain capability was allocated that critical task, thereby jeopardising the safety of the product. The committee also pointed out that the project was “poorly planned” and lacked supervision from the project head and the institution heads despite this being considered “a project of national importance”.

Institutional and other issues: Equally egregious were the failings on the institutional and ethical fronts. ICAR blatantly disregarded the Material Transfer Agreement (MTA) signed by its scientists and claimed somebody else’s materials. In addition it compelled its own scientists to remove the name of the original developer of the construct disregarding the MTA. The committee suggested that, “ICAR should think about not taking policy decisions of this nature that would compromise the ability of its scientists to take ethically correct decisions.” While the motives for such action remain murky, there cannot be a clearer indictment of the lack of ethics in the functioning of the ICAR system.

Regulatory issues: On the GM crop regulatory front instances of regulatory failure are piling up. The report has pointed out the clear conflicts of interest. Developers were sitting in the GEAC meeting as regulators and approved their own product! The committee expressly recommended that conflict of interest of this kind should be weeded out from the system. Molecular characterisation is a crucial and primary component of the biosafety testing regime – the scientists here got away undetected with the Monsanto event in their product!

1 Full report at this link  http://www.icar.org.in/en/node/5511