Info body gives bio-tech dept a RTI power-punch

[ganpat1956]

NEW DELHI, APR 13: In a verdict which may have a far-reaching consequence in the future, the Central Information Commission (CIC) on Friday directed the department of bio-technology (DBT) to make public the data generated from the tests carried out on transgenic crops by agro-biotech companies.

Chief commissioner Wajahat Habibullah delivered this right to information (RTI) power-punch, in response to an petition filed by Greenpeace India, after the review committee on genetic modification (RCGM) under DBT consistently refused to part with this closely guarded secret for over a year. Striking down the DBT's contention that the data falls under Section 8.1.(d), Habibullah pointed out that the request of the applicant for toxicity and allergenicity tests on genetically modified (GM) rice, mustard, okra and brinjal cannot be refused under the RTI Act. Any further grounds for non-disclosure are invalid even if the data in reference are in the process of development. The information was also directed to be disclosed under section 4. (1). (d) of the RTI Act, which states " provide reasons for its administrative or quasi judicial decisions to affected persons.� Supreme Court advocate Prashant Bhushan who appeared pleaded before the CIC on behalf of Greenpeace India said,� The Commission's order is significant as past experience shows that RCGM has not used the right kind of protocols for bio-safety testing". In February, last year, Greenpeace India had requested the RCGM to make public the toxicity and allergenicity data for four GM crops alongwith the minutes of the meeting. "Our victory today is in keeping with the spirit of the RTI, and has only strengthened the RTI as a tool to building a participatory democracy, " Divya Raghunandan of Greenpeace India.

Info body gives bio-tech dept a RTI power-punch

[ganpat1956]

A better version of the same news is reported in Times of India. The same is reproduced here for the benefit of members

NEW DELHI: If a genetically modified (GM) food causes allergies or contains toxins, can the government refuse to disclose such bio-safety information on the grounds that it involves "commercial confidence" or "trade secrets" and that it will compromise the "competitive position" of the bio-tech company concerned?

Central Information Commission (CIC) said no on Thursday and ordered the department of biotechnology to disclose toxicity and allergenicity data on transgenic food crops that are being field-tested across the country.

In a far-reaching interface between RTI and environmental protection, the head of CIC, Wajahat Habibullah, directed the government to make public within 10 working days all the relevant data on genetically engineered brinjal, okra, mustard and rice which have been approved for multi-location trials.

The order came on an appeal filed by a Greenpeace activist, Divya Raghunandan, against government's refusal to disclose the data saying it was covered by Section 8 (1)(d) of RTI Act which exempts from disclosure "information, including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party".

While arguing for the disclosure of the toxicity and allergenicity data, Raghunandan cited a recent rat-feeding study in Europe by three French scientists who, despite the efforts of bio-tech major Monsanto to keep the matter under wraps, established that a genetically modified maize brought out by that company was not a safe food.

Raghunandan also drew attention to an alarming admission made by the government in response to her RTI application.

Although it has approved their multi-location field trials, the government said that the data on rice, okra and mustard was "under development" and "yet to be evaluated" by it. Such laxity in regulation, she said, could lead to genetic contamination in the areas where field trials were being held even before the toxicity and allergenicity data had been analysed.

Given the obvious public interest in the health risk assessment of genetically modified foods, CIC observed that the government should be, under Section 4 of the RTI Act, proactively putting out all the relevant data without waiting for applications for their disclosure.

But CIC declined Raghunandan's plea for making public the minutes of the meetings of the Review Committee on Genetic Modification (RCGM), which approved the various proposals of multi-location field trials of genetically modified food crops.

Since RCGM's minutes mention details of the proposals made by each of the bio-tech companies, Habibullah chose to leave it to the government to take a call on whether those confidential documents could be made public.

CIC orders govt to divulge toxicity of GM foods-India-NEWS-The Times of India

[sidmis]

The Central Information Commission (CIC) has directed the government to make public information on safety tests data of a genetically engineered crop, while noting that such details need to be divulged as a matter of "public interest."

The Department of Bio-technology (DBT) which failed to comply with the Commission's order passed in April this year to disclose details about toxicity and allergenicity data of four genetically modified (GM) crops, has now been directed to divulge data on BT brinjal.

The CIC's order of April 13 had also directed DBT to disclose bio-safety data of rice, okra (lady's finger) and mustard, after an Right to Information application was filed by Greenpeace activist Divya Raghunandan.

The information about these three GM crops were denied on reasons that the relevant data was yet to be generated. DBT has been directed to the release the data within a stipulated time frame.

"It is quite clear that genetically engineered organism or cells are recognised by government as an item potentially hazardous to public health. It automatically follows that full compliance with the rules is a matter of public interest," Chief Information Commissioner Wajahat Habibullah said.

The DBT had also attached a request from Maharashtra Hybrid Seeds Company Ltd (MAHYCO), which had stated disclosure of any information apart from that of relevant summary tests studies, available on the portal of Genetically Engineering Approval Committee (GEAC), would affect their competitive interest. The company's request was turned down by the CIC.

Raghunandan also contended before the Commission that she be granted a compensation of Rs 50,000 for the delay of time and money in chasing the information request filed 20 months ago. The applicant has been asked to provide the CIC details of loss suffered for assessment.

New Delhi (PTI)
The Hindu News Update Service

[karira]

As reported by Joe C Mathew on business-standard.com on 21 March 2008:
Monsanto, Greenpeace clash over GM brinjal safety in India

Monsanto, Greenpeace clash over GM brinjal safety in India

The MNC's seed partner doesn't want details of its safety test in the public domain.

A case filed in the Delhi High Court will decide the fate of exclusive data shared by companies with the government. Companies, especially those in the pharmaceutical and agri-chemicals businesses, don’t want such data to be made public in order to protect their commercial interests.

Maharashtra Hybrid Seeds Company Ltd (Mahyco), the seed partner of multinational agro-biotech major Monsanto Corporation, has moved the Delhi High Court against a Central Information Commission order seeking details of the safety test data generated during clinical trials of its genetically modified (GM) brinjal, the first GM edible crop to be introduced in India.

Mahyco had submitted the data with the department of biotechnology for regulatory clearances. Divya Raghunandan, a representative of global environmental watchdog Greenpeace, had sought this information under the Right to Information (RTI) Act.

The department turned down the plea on the grounds that the information sought by Greenpeace included “commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party�.

Overruling the department, the Central Information Commission found merit in the Greenpeace argument that the data were not meant for commercial purposes and was sought to ascertain the risks that transgenic crops pose, particularly when open air field trials are being conducted in several places across the country.

Mahyco has gone to court to keep the data from being put out in the public domain. In its petition, it has also said that the Central Information Commission’s order violates the obligations of India under the Trade- Related Intellectual Property Rights Agreement of the World Trade Organisation.

The Delhi High Court passed an interim order in December 2007 staying the order till the next hearing of the case on April 23.

Some activists have thrown in their lot with Greenpeace. “The RTI Act clearly overrules any other rule that provides ‘data protection’ if the public authority is satisfied that larger public interest warrants the disclosure of such information,� RTI activist Prashant Bhushan said.

However, the department of biotechnology has said that the regulatory clearance for conducting trials of Mahyco’s brinjal was given after proper scrutiny and they pose no public health hazards.

Greenpeace has obtained similar data on Monsanto’s genetically modified insect resistant maize in Europe through a court order. The Monsanto data, when independently evaluated, had given rise to conclusions that were contradictory to Monsanto’s observations.

Armed with the new data, the international NGO had launched a campaign, though not with much success, to see that the marketing approval given to the particular maize variety (MON 863) in Europe was withdrawn. Greenpeace is looking at the possibilities of a similar review of the data generated by Mahyco for its brinjal variety..

[karira]

As reported by Vibha Varshney DOWN TO EARTH - Science and Environment Magazine on 04 April 2008:
MAHYCO refuses to share safety data on GM crops | News | Down To Earth magazine

MAHYCO refuses to share safety data on GM crops

New Delhi, April 4: The Central Information Commission (CIC) has pulled up the public information officer of the Airports Authority of [COLOR=blue ! important][COLOR=blue ! important]India[/color][/color] (AAI) for not providing information in the stipulated period of one month.


AAI PIO B.V. Subha Rao of the Chennai office has been found to have violated the provisions of the act and issued a showcause notice as to why he should not be penalised.


Taking a stern view of the delay in providing the information, information commissioner M.M. Ansari pulled up CPIO B.V. Subba Rao of the Chennai office, where the information was filed. He said the CPIO is held responsible for violation of Section 7(1) of the act as he did not respond within the stipulated period of 30 days. The application was replied after nearly four months. The CPIO is, therefore, directed to show cause as to why a penalty of Rs 250 per day, up to a maximum of Rs 25,000, should not be imposed on him for the delay in furnishing the information.


The CIC also directed him to submit his explanation within 15 working days and also appear for a personal hearing on May 23, failing which penalty would be imposed.


The applicant, Mr V. Francis Xavier, filed an application under the Right to Information Act to the Airports Authority of India.


The applicant and others had grievances relating to fixation of scale of pay. In this context, they had made various representations for rectification of anomaly in the scale of pay. They alleged that no worthwhile action was taken and so they sought to know the status of the action taken on their application through and application under the RTI Act.

[karira]

As reported by TNN on timesofindia.indiatimes.com on 09 April 2008:
http://timesofindia.indiatimes.com/I...ow/2936225.cms

Centre nod to make public toxicity data of GM crops

NEW DELHI: After persistently refusing right to information applications seeking access to the toxicity and allergenicity data relating to genetically modified crops, the Centre on Tuesday agreed before the SC to make these public, much to the joy of anti-GM crop campaigners.

The government's refusal to part with this information had led to petitions filed by NGO "Gene Campaign" and Aruna Rodrigues, who alleged that the data had vital bearing on the safety of human beings and environs.

When the matter came up for hearing before a bench comprising Chief Justice K G Balakrishnan and Justice R V Raveendran, counsel for petitioners — Sanjay Parikh and Prashant Bhushan — said the companies experimenting with GM crops could not claim privacy and copyright over the data as it did not relate to the manufacturing process but about the future damage potential of the crop.

At this point, additional solicitor general Amarandra Saran, in what marked a major shift of stance, told the bench that the government was willing to put all data relating to toxicity and allerginicity of the GM crops, which are under experimentation prior to field trial, on the official website.

Just two years ago, the Department of Bio-Technology had rejected an RTI appeal on the issue and said: "The toxicity and allergenicity data being generated on transgenic crops that are yet to get the approval for commercial cultivation, is the intellectual property of the applicant."

"It also has commercial value and disclosure of information on the same is likely to adversely affect the competitive advantage of the applicant generating the data as it can be taken as publicly available information by the competitors in the same field."

[karira]

As reported by Special Correspondent in hindu.com on 15 April 2008:
The Hindu : Front Page : Legal tussle over giving out data on bio-safety tests of transgenic crops

Legal tussle over giving out data on bio-safety tests of transgenic crops

MUMBAI: While the Supreme Court last Tuesday ordered that bio-safety tests on transgenic crops should be made public, there is a petition pending in the Delhi High Court, which has issued a stay on giving out data on bio-safety tests of genetically engineered brinjal which is under trial.

The company testing transgenic brinjal, Maharashtra Hybrid Seed Company (Mahyco), got a stay last year on the order of the Central Information Commissioner (CIC) asking the department of biotechnology (DBT) to part with data on bio-safety tests of transgenic brinjal.

Greenpeace is about to challenge Mahyco’s contentions by filing an affidavit by April 23 in the Delhi High Court. Greenpeace activist Divya Raghunandan sought information on bio-safety, toxicity and allergencity tests on transgenic crops like okra, mustard, brinjal and rice under the Right to Information (RTI) Act. In April 2007, the CIC asked the DBT to provide all bio-safety data available with it saying that “any further grounds for non-disclosure are invalid even if the information was still in the process of development.”

However, on May 30, 2007, the DBT provided only the names of tests, protocols and result summaries derived from the data for genetically engineered brinjal, but not actual ‘data’ as requested. the DBT said since the data on toxicity, allergencity and other bio-safety data ran into thousands of pages, it could be scrutinised in the Ministry of Environment and Forests in the presence of a Genetic Engineering Approval Committee (GEAC) representative. There was no data given on the other three crops, rice, okra and mustard, and the DBT said it was still being generated.

The CIC heard the case again on the basis of a non-compliance petition filed by Ms. Raghunandan on November 12, 2007. Mahyco also appealed on the grounds that the data at stake had immense implications for its commercial interests and that it was never given a chance to represent its case. This, however, was rejected by the CIC as he felt that the argument that it would affect a third party was addressed before and it did not arise now.

Again on November 22, 2007, the CIC ordered the DBT to provide the requested information within ten working days or provide Ms. Raghunandan the time frame it needed.

However, Mahyco approached the Delhi High Court and obtained a stay on the order of the CIC on December 6, 2007.

It has also sought to quash the order on the grounds that the disclosure of the bio-safety information of transgenic crops will affect the commercial interests of the company. For, bio-safety data falls under the protected confidential information covered by the Trade Related Aspects of Intellectual Property Rights (TRIPS) regime and is to be considered an intellectual property of the company.

Mahyco managing director Raju Barwale in a statement to The Hindu said, “All of our information has been submitted to respective committees designated by the Government of India for appropriate review and analysis. The summary of our research data is also available on the DBT website.

Our petition is about not following the process laid out under the Right to Information (RTI) Act, [it is] about violation of the principles of natural justice, about protection of confidential trade data from competitive interests permitted under the RTI Act and to avoid a law and order problem in view of instances of attacks on the field trials, again permitted under the RTI Act.” Mr. Barwale said, “We are unable to discuss this any further in view of the matter being sub judice.”

[opsharma]

The brinjal battles

An ongoing case on genetically modified brinjals has led to questions being raised on the Right to Information Act. Rahul Jayaram reports

It’s an unlikely candidate for controversy, but the lowly brinjal is at the heart of a battle. The issues at stake: whether agricultural and pharmaceutical companies should share classified data (read: trade secrets) with the government and independent watchdogs. The two sides in this joust: the Indian partner of a US-based biotech firm that’s trying to ease in a new version of a genetically modified (GM) brinjal, on the one side, and the environmental group Greenpeace and, indirectly, the Central Information Commission (CIC), on the other.
Last month, the Maharashtra-based Mahyco, the Indian partner of US agro-biotech firm Monsanto, moved the Delhi High Court against a CIC order seeking details of the safety test data generated during clinical trials of its GM brinjal — the first GM edible crop that is to be introduced in India.
Greenpeace had first filed the suit against Mahyco two years ago, invoking the Right to Information (RTI) Act, asking for details about its safety. But the case, Greenpeace claims, has shown the other side of the RTI, which has been hailed as a revolutionary initiative in contemporary India.
“The RTI may have been one of the most people-empowering ideas in the country,” says Divya Raghunandan of Greenpeace who filed the first suit against Mahyco in February 2006, “but it has attributes which makes it prone to manipulation and obfuscation, especially by companies. Our legal experience with Mahyco attests to that.”
The suit begs several questions of the RTI. Is it too open-ended? Are its clauses stacked in favour of companies? Does its functioning need to be addressed? Mahyco, on its part, has declined to share its views on the issue. “We cannot comment on this issue,” said a senior Mahyco official.
At the heart of this matter is the public’s right to access information regarding what food will be on its plate in the future. Mahyco has plans to first bring in the GM brinjal, followed by genetically modified varieties of mustard and rice. Greenpeace and others involved in the case argue that the fact that Mahyco has dilly dallied about revealing data makes the matter suspicious.
To be sure, such battles are not new in the West. Monsanto’s reputation took a hit when a variety of its GM corn seeds was slapped with a ban in Germany last May. The German federal ministry had then stated that Monsanto’s MON 810 corn seeds posed a danger to the environment and that the company hadn’t given the agriculture ministry a detailed crop monitoring plan. Mahyco, Greenpeace contends, seems to be treading the same path.
But Mahyco has regularly invoked Section 8.1d of the RTI Act, which gives companies the right to withhold information which may let out a trade secret or infringe intellectual property rights unless it’s proved that the disclosure of such information is essential to the interests of the public at large.
What is more, Rajya Sabha MP and agricultural leader Sharad Joshi is sceptical about the environmentalists’ efforts, stressing that such cases hamper development. “GM seeds may or may not be as productive as other seeds. But they are not designed to be harmful in the way they are understood to be,” says the founder of the peasant organisation, Shetkari Sanghatana, “Throughout history organisations and individual groups have opposed modernity. When factories came, they opposed them, saying these would kill agriculture. When trains came they opposed them, saying that they would harm the environment. When computers came they said they would take away all the jobs. But look at what happened — India progressed. These are regressive forces.”
Others demur. “Of course such disclosure is essential. It’s about food, about public health. There can be no compromise on that,” says activist Nikhil Dey of the National Campaign for Right to Information (NCPRI). “When you’re confident about the nature of your product, you won’t hesitate revealing what it’s like or what it’s made of. If you’re iffy about it, people raise eyebrows... This is the profit motive talking.” NCPRI is a movement of committed individuals working towards making the Indian government and society more transparent and accountable. It had a big hand in pushing for RTI and consists of noted activists like Aruna Roy, Shekhar Singh and Dey.
As for the question of protecting intellectual property rights, Supreme Court lawyer Prashant Bhushan, who is the lawyer for Greenpeace, is quick to point out that “there are no patent rights for GM products in India as of now. So that argument is not tenable”. R. Jai Krishna, a Greenpeace campaigner for sustainable agriculture, stresses that data obtained from the field tests conducted by Mahyco can be copyrighted, not patented. Information can be copyrighted, products are patented. In any case, Indian law doesn’t have any provision for patenting GM products as yet. The larger point that emerges is how the case appears to have allowed Mahyco to use different provisions within the RTI to shift positions and give summaries of field reports, not hard data.
Yet Greenpeace and other activists are not pushing for changes to the RTI. “I wouldn’t recommend touching the broad framework,” says Dey, “but I’d like to see more specific expert input in the legal system. The inherent bias towards company rights needs checks, and should have riders added whenever required.”
Jai Krishna suggests that an interesting way to work around this is to keep a watch on related monitoring bodies as well. “The issue is the functioning of the RTI and the agents that make this happen, not the RTI per se,” he emphasises.
For example, in the current case the data given out by Mahyco whenever instructed to do so — which Greenpeace anyway feels isn’t entirely relevant to the safety aspect —were studied by a review committee appointed by the department for biotechnology (DBT) under the order of the CIC. But “a government-appointed review committee must have people who are asking the right questions, analysing the right data and doing the right tests”, he says.
“In May 2007, the DBT provided only the result summaries of the data that are derived from the data for genetically engineered brinjal. Also, it directed the appellant to go to the ministry of environment and forests and take down the thousands of pages of data under the supervision of an officer. No data were given on the other three crops — rice, okra and mustard,” he says.
But K.K. Tripathi of the review committee on genetic manipulation (RCGM) of the DBT, and part of the review committee on the case, is unaffected by any finger pointing. He’s also very noncommittal. “We are doing what is asked of us by the CIC. There’s a process in place and we adhere to it. The results of the tests and data analyses are routinely put out. The high court will decide what is to be done,” he says.
But one thing is for sure. Little did we know a brinjal could have the potential to stir up the Indian legal system. Call it vegetable power?

The Telegraph,Calcutta,14 May 2008.

[karira]

As reported in hindu.com on 08 June 2008:
The Hindu : Magazine / Environment : The colour purple

The colour purple

The debate over transgenic crops continues to rage as India’s first GM food crop, brinjal, gets ready for release. Meena Menon

“There was no barrier around the whole field and I visited the field five times, which should not have been allowed,” said Selvam. R. Selvam, president of the Erode District Organic Farmers Federation

First cotton; now brinjal. Both have their centre of origin in India and this must be one of the few countries where there has been very little debate on the safety or even necessity of genetically modified (GM) crops. While Bt cotton is already grow n in India, there are growing protests against the release of India’s first GM food crop: brinjal.

In one sense, India shares with other countries the rather dubious record of not sharing data on the safety of transgenic crops. The Genetic Engineering Approval Committee (GEAC) maintains that all research data is up on its website.

However, Divya Raghunandan of Greenpeace had to file a Right to Information (RTI) petition to demand the reports of bio-safety and other tests. While the Chief Information Commissioner has ordered the Department of Biotechnology (DBT) to part with the information, the DBT has shown a marked reluctance to do so, insisting that the records were voluminous and she should inspect it under supervision in the office.

A non-compliance petition was filed before the CIC and once again the DBT was directed to give the information. Meanwhile Maharashtra Hybrid Seeds Company (MAHYCO) got a stay from the Delhi High Court.

In February, the Tamil Nadu Agricultural University (TNAU) in Coimbatore had banners across its entrance saying it was now owned by Monsanto. This was after farmers found that it was conducting field trials of transgenic brinjal being developed by Monsanto’s partner MAHYCO on the campus.
Violations

R. Selvam, president of the Erode District Organic Farmers Federation, wrote to the GEAC listing the violations in the field trials at TNAU. He said the prime violation was the refugia or the buffer zone stipulation. Instead of five rows there were two rows, and that too with a lot of gaps. Another major violation was that the brinjals were dumped in an abandoned well, instead of being burnt.

“There was no barrier around the whole field and I visited the field five times, which should not have been allowed,” said Selvam. He says the University is maintaining a germ plasm of traditional brinjal varieties, which is why the trial of transgenic brinjal is absolutely unacceptable. The priorities of research are totally misplaced, he pointed out. “Millions of coconut trees are infected with termites in the state but the University is conducting trials of Bt brinjal.”

Dr. Veeraraghavan Thatam, Dean, TNAU Horticultural College and Research Institute, Coimbatore, said that it was very difficult to convince people about the science of transgenic crops, which only helped give crops resistance to pests. He said transgenic brinjal was designed to resist the fruit and shoot borer, which often decimated the crop.

He said all the rules set by the Department of Biotechnology were adhered to and the tested brinjals were incinerated. The research studies are on the website and people were free to read it, he pointed out. The GEAC, in turn, said that it would examine all aspects of the issue and only then take a decision.

While field trials of GM crops are in progress since five years or so, very little information was available till Greenpeace filed an RTI petition. In 2005, for the first time, there was a clear picture of the genetic experiments on food crops being conducted in India. There were 21 different food crops being engineered, mainly rice, brinjal, okra, tomato, cabbage, cauliflower, mustard, groundnut, pigeon pea, potato, corn.

Almost all these crops have been engineered with the insect resistant gene (Cry1 Ac) also referred to as the Bt gene.
Lack on information

In fact Aruna Rodrigues’ petition in the Supreme Court was spurred by concerns on lack of information on biosafety and regulation. In India, before a GM crop can be commercialised, it must go through glasshouse trials, then two years of multi-location research trials in open fields and then large-scale trials. Only transgenic brinjal has reached the stage of large-scale trials.

On May 8, 2007, the Court directed that there must be 200 meters isolation distance between the trial fields and the neighbouring fields cultivating the same crop to avoid contamination. The GEAC will examine this issue and prescribe the isolation distance depending upon the nature of the crop.

Two intervening applications in the Supreme Court complained that the data regarding toxicity and allergenicity have not been placed in public domain by those conducting the trials, with regard to nine crops to be field tested.

While the government told the apex court that, as regards Bt cotton and Bt brinjal, required data has already been put on the website; in regard to seven other crops, data is being collected and as soon as the full data is available with the GEAC, it would be put on the website.

Greenpeace points out that field trials are open-air experiments conducted in fields. They pose a risk to the environment and health because these untested GM plants could cross pollinate and contaminate nearby crops, and related wild varieties. Rice exporters protested against the testing of GM rice in the basmati growing areas last year and the government took a policy decision not to allow field trials in basmati growing areas. It has already stopped transgenic research in basmati rice.

Even in the case of Bt cotton, field trials between 1995 and 2001 were supposed to evaluate the economic, social and environmental impact. But an illegal Bt cotton hybrid was found growing on over 10,000 acres in Gujarat, which completely exposed the lack of regulation.

In 2005, 21 civil society organisations across six states across the country formed the Monitoring and Evaluation Committee (MEC) since the one set up by the government was not doing its job. The MEC documented 19 cases of field trial violations where farmers mixed the field trial produce with non-GM cotton and sold it in the market.

Already, transgenic rice, groundnut, brinjal, okra, tomato, groundnut cauliflower and cabbage are being tested in India.

While civil society groups are stepping up pressure with all-India protests, it is time the government reviewed its experience with transgenic cotton before embarking on clearing other crops.

[karira]

As reported by Ashok B Sharma in financialexpress.com on 09 June 2008:
Monsanto suggests provision for maintaining data confidentiality

Monsanto suggests provision for maintaining data confidentiality

New Delhi, Jun 8 The seed multinational, Monsanto has suggested inclusion of the provision for maintaining data confidentiality in the draft National Biotechnology Regulatory Authority Bill-2008.

Monsanto India’s manager of regulatory affairs, Devraj Arya said : “It is a good thing to have a single window clearance of genetically modified (GM) products, but the new law should ensure data confidentiality. This is absolutely necessary in the IPR regime and we cannot afford to stand the risk of making such sensitive data public.”

The department of biotechnology (DBT) has drafted a Bill, which would allow setting up of a autonomous National Biotechnology Regulatory Authority (NBRA) as a single window clearance for GM products.

Recently, Greenpeace India had asked Mahyco, which has developed Bt brinjal with technology sourced from Monsanto, to reveal some biosafety data. The Central Information Commission had ordered Mahyco to disclose the data. which was refused by Mahyco under the Right to Information Act and went with an appeal before the Delhi High Court.

The proposed Bill, if passed by the Parliament, would take away the provisions of regulation of GM products from some existing laws like the rules for manufacture, use, import, export and storage of hazardous micro-organisms, genetically engineered organisms or cells, 1989 issued under Environment (Protection) Act 1986, Food Safety and Standards Act, Drugs and Cosmetic Act, Drugs and Cosmetic (Amendment) Bill-2007, Seed Bill-2004, draft Plant Quarantine Bill, National Biological Diversity Act and Plant Varieties Protection and Farmers’ Rights Act.

In a consultation session on the draft Bill convened on Friday, the member of Parliament, Sharad Joshi criticised setting up of the NBRA. He said : “The government sets up an authority only to rehabilitate retired government officials as its chairman and members.”

Noted activist, Vandana Shiva of Navdanya criticised the move to place NBRA under the promoter agency, DBT and said the position of the existing regulator, GEAC under the environment ministry was better.

Though the draft Bill has proposed an inter-ministerial advisory body, its decisions are not binding for NBRA. The Union government can intervene only on policy matters. NBRA would also usurp the powers of the state governments by setting up its own state bodies.

[sidmis]

Biosafety data of transgenic brinjal made public
as reported by Meena Menon, Monday, Aug 25, 2008, The Hindu

MUMBAI: The Genetic Engineering Approval Committee (GEAC) has published information on biosafety studies of Bt brinjal, developed by MAHYCO, on its official website. The data in eight volumes, runs into more than 1,100 pages.

Sources in the Department of Biotechnology (DBT) confirmed that it was the complete data sent by the company which was analysed by the department and forwarded to the GEAC. Greenpeace, which has been demanding that the data be made public and is involved in a long Right to Information (RTI) battle, says the data looks comprehensive, but there is neither an official notification nor an assurance of its completeness from the authorities.

However, MAHYCO had sought a stay on the data being made public after an order of the Central Information Commissioner (CIC) last November. The Delhi High Court did grant the stay in December 2007 after MAHYCO, the Indian partner of the multinational agri biotech giant Monsanto, said the company could suffer commercial losses if the confidential data was disclosed to the public.

In the last hearing of the case in Delhi on August 20 there was no mention of the data being available on the website. Since the issue was sub judice and the DBT was one of the respondents it could not make the data public. DBT sources said there was nothing secret about the data and the only reason it did not share it with Greenpeace was because of the company’s objections as a third party that their business interests would be affected. Now GEAC in its own wisdom has decided to post the data on the Internet.

Greenpeace said it has been close to 30 months since the first application for the biosafety data and minutes of the Department of Biotechnology (DBT) committee meetings were submitted under the RTI Act 2005 by Divya Raghunandan. Since then the data was consistently denied by the DBT till the CIC directed the department to disclose the data to the appellant finally in November 2007.

Though it had come very late, this was a welcome step by GEAC, said Divya Raghunandan of Greenpeace who had filed the RTI way back in February 2006. Recently, Dr. P.M. Bhargava, special invitee of the Supreme Court in the GEAC, raised concerns on the veracity of the Bt cotton as well as the Bt brinjal data as the procedures followed were flawed.

The Hindu : National : Biosafety data of transgenic brinjal made public

[karira]

As reported by Joe C Mathew in business-standard.com on 07 September 2008:
Ministry panel reveals data on GM brinjal

Ministry panel reveals data on GM brinjal

Data on clinical trials of genetically-modified (GM) brinjal have been made public by the Genetic Engineering Approval Committee (GEAC) of the environment ministry.

The development comes even as Maharashtra Hybrid Seeds Company (Mahyco) had filed a petition before the Delhi High Court to prevent disclosure of the details of clinical trials on GM brinjal by the Review Committee on Genetic Modification of the Department of Biotechnology (DBT).

Since the Mahyco litigation is considered by the industry as well as public interest groups as a test case for deciding the fate of exclusive data shared by companies, especially pharmaceutical and agri-business entities, with the government for regulatory approvals, the GEAC decision has raised questions about the “confidentiality” claims made by research-based companies on their clinical trial data.

While GEAC gives marketing approvals for genetically-modified products, the research of such products are scrutinised by the review committee.

The move has come as a welcome surprise for global environmental watchdog Greenpeace, which has been trying to get the details of the clinical trials for an independent scrutiny for the last 30 months.

Mahyco said it continued to believe in the confidentiality of the clinical trial data that is submitted to government agencies for regulatory approvals. DBT officials said the court case has no relevance as the data, which were termed as confidential, are now in public domain.

It has been close to 30 months since the first application for the bio-safety data and minutes of the DBT committee meetings were submitted under the RTI Act