1.Expert Panel was under pressure to clear Bt Brinjal
2.India's GM Scandal: Bt Brinjal Approval Rigged
---
---
1.Expert Panel was under pressure to clear Bt Brinjal
CNN-IBN EXCLUSIVE
PRESS RELEASE: November 30 2009

Dr Pushpa Bhargava, the Supreme Court's independent nominee to the GEAC (Genetic Engineering Approval Committee) writes to Environment Minister Jairam Ramesh on Oct 20, 2009.

Dr. Bhargava says that Professor Aruja Reddy made a confidential call to him and said that 8 of the tests that should have been done were not done.

Dr Bhagava says that Professor Reddy told him that he was under "tremendous pressure" to clear Bt Brinjal and had calls from the Agriculture Minister, GEAC and Industry

Dr Bhargava says that Professor Reddy told him that he was in a dilemma.

CNN-IBN also spoke to Professor Arjula Reddy, the chairman of EC 2....

When asked if he was under pressure since he headed a powerful committee, Professor Reddy did not deny that he was under pressure, he told CNN-IBN, "you think this is powerful... the decisions were already taken by the Review Committee on Genetic Engineering (the RCGM)"    

When repeatedly questioned, Professor Reddy said, "Dr. Bhargava was his friend and his commitment to science or public health cannot be questioned... I am a government servant, I cannot talk".

When asked whether Professor Reddy was happy with the report, he said, "chairman of the committee will never be happy in any committee...it is part of life, that's all I can say at this stage... I tried my best to raise questions and look at data as critically as possible".

Environment minister Jairam Ramesh declined to comment on the letter.

------------------------------

In Detail

On 14 of October, the expert panel (EC 2) gave the go ahead for Bt Brinjal. Now, the decision of whether Bt Brinjal will be made commercial rests with Minister of Environment Jairam Ramesh.

According to details available exclusively with CNN-IBN, the decision was taken under pressure. Dr. Pushpa Bhargava, the Supreme Court's Observer to the GEAC has written a letter to the GEAC and the environment minister, Jairam Ramesh. This letter was sent on the 20th of October.

In this letter Dr Pushpa Bhargava has said that Professor Arjula Reddy, the chairman of EC 2 made a confidential call and told him that eight of the tests that should have been done were, infact, not done. Professor Reddy also said that he was under " tremendous pressure " to clear Bt Brinjal.... and had calls from the," agriculture minister, GEAC and industry ".

Professor Reddy told Bhargava that he was in a dilemma. CNN IBN spoke to Professor Reddy and asked him if he was under pressure as Dr Bhargava has said. Professor Reddy did not deny that he was under pressure. He said, " you think this is powerful... the decisions were already taken by the Review Committee on Genetic Engineering (the RCGM)".

He further added, "Dr. Bhargava was his friend and his commitment to science or public health cannot be questioned... I am a government servant, I cannot talk".

Asked if he was happy with the performance of the panel, he said, " chairman of the committee will never be happy in any committee...it is part of life, that's all i can say at this stage... I tried my best to raise questions and look at data as critically as possible".

Dr. Bhargava in his letter says, "the only conclusion was that he succumbed".  Dr. Bhargava's letter and Professor Reddy's comments will only deepen the controversy surrounding Bt Brinjal.
---
---
2.India's GM Scandal: Bt Brinjal Approval Rigged
Devinder Sharma
Devinder Sharma Blog, 30 November 2009
http://www.countercurrents.org/sharma301109.htm

Now it can be told. The environmental clearance by an Expert Committee (called EC-II) set by the Genetic Engineering Approval Committee (GEAC) to accord approval to the controversial genetically modified crop -- Bt brinjal -- was actually rigged. This was never in doubt, except that this time Kavitha Kuruganti of the Coalition for GM Free India has very meticulously joined the dots to bring out this shocker.

As a consumer, you need to understand how you are likely to be served poisonous food by a bunch of people (who operate in the name of scientists) whose only job is to promote the commercial interests of the private seed and biotech companies. The conflict of interest of most of the members of the EC-II comes out clearly in this exposure.

The entire regulatory system has in fact become subservient to the US interests. The Indian Council for Agricultural Research is now completely in the hands of the US Artificial Insemination Department (USAID), and so is the Department of Biotechnology. And if you think the Ministry for Health and Family Welfare is any better, you just have to walk into the corridors of the ministry. You can hear the whispers clearly.

Ever since the Indo-US Knowledge Initiative in Agriculture, Research and Marketing (KIA) was put into place (almost the same time the Nuclear treaty was signed), the ICAR does exactly what the USAID wants it to do. The outgoing Director General Dr Mangla Rai is merely a figure head, an Indian face for the American operations.

Let me share with you some excerpts from the damming report. Sorry, even the excerpted portions of the report are pretty long.

IS THIS WHAT INDIANS SHOULD BE TRUSTING?
The story of the Expert Committee that recommended Bt Brinjal for commercial cultivation in India

On October 14th 2009, the apex regulatory body for GMOs (Genetically Modified Organisms) in India - the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment & Forests (MoEF), gave a go-ahead for the commercial release of Bt Brinjal, the first ever such Genetically Modified (GM) food crop anywhere in the world with the toxin-producing Bt gene in it. The GEAC based its decision, with some dissenting voices recorded, on the recommendations of an Expert Committee (referred to hereafter as EC2, specifically referring to this expert committee on Bt Brinjal, as opposed to EC1, another Expert Committee constituted in 2006-07).

EXPERT COMMITTEE 2 ON BT BRINJAL

When independent reviews of Mahyco’s biosafety data started coming in, in the month of January 2009 (after the data was put up on the Indian regulators’ official website in October 2008 after a protracted Right To Information struggle and after the Supreme Court passed orders to this effect), the GEAC in its meeting on 14th January 2009, decided to set up an Expert Committee (a Sub-Committee, as it was called at that time). The decision in this 91st meeting of the GEAC was recorded as under:

“5.1.4 After detailed deliberations, the Committee decided to set up a Sub-committee comprising of representatives from the Ministry of Health and Family Welfare, NIN, ICMR, CFTRI, CCMB, IIVR, NDRI, CFIE, MoEF, DBT, TNAU and UAS Dharwad with the following terms of reference:

- to review the adequacy of the biosafety data on Bt brinjal

- to review the adequacy of the toxicity and allergenicity protocols

- to suggest further studies, if any, based on the review of the international practices in biosafety assessment and representations received by the GEAC

- based on such reviews make suitable recommendations for consideration of the GEAC”.

On February 10th and 11th 2009, many faxes were sent from civil society groups across the country asking GEAC to review the mandate for the Sub-Committee and to remove conflicting interests in the committee.

As per an Office Memorandum dated 29/5/2009, the GEAC constituted an Expert Committee consisting of 16 members, headed by Prof Arjula R Reddy, Vice Chancellor of Yogi Vemana University, Hyderabad and currently also the Co-Chair of GEAC.

Interestingly enough, the Terms of Reference for this Committee were:

- to review the findings of the data generated during the large scale trials ;
- to review the biosafety data of Bt brinjal in light of the available scientific evidence, reports from international/national experts and representations from NGOs and other stakeholders;
- to make appropriate recommendations for consideration of the GEAC based on the above review.

One could argue that this new ToR itself is a departure from the decision taken in the January meeting of the GEAC, with regard to the rationale for the constitution of the committee. Further, it has to be noted that the large scale trials’ findings along with findings from pollen flow, soil impacts and crossability studies were put in the public domain only on November 16th 2009, a full month after the Expert Committee came up with its recommendation and this did not go through any independent analysis or review.

On and around the 30th of July, soon after the office memorandum was put up in the public domain, civil society groups once again wrote to the GEAC pointing out to the need to change the mandate of the Expert Committee as well as the inclusion of conflicting interests in the constitution of the Expert Committee (Annexure 1). In addition, on 2nd September and on 11th October 2009, in email communications sent to the Hon’ble Minister for Environment & Forests, these issues have been raised with him too, to update him and seek his intervention.

It has to be noted here that an earlier Expert Committee (EC1) set up in 2006 also presented similar issues for the country, when a GM crop developer was asked to head that Committee. It was only in the second meeting of this EC1 that the GM crop developer was replaced by another scientist.

“EC 2 DESIGNED TO APPROVE BT BRINJAL”

The EC2 had 16 members including the following:

Prof. Arjula R. Reddy, Vice Chancellor, Yogi Vemana University, Hyderabad and Co-chairman, GEAC (Chairperson of the EC2).
Dr Vasantha Muthuswamy, Former Chief (BMS), ICMR, New Delhi: Member
Dr. B. Sesikaran, Director, National Institute of Nutrition, Hyderabad: Member
Dr. Lalitha R. Gowda, Scientist, CFTRI, Mysore: Member
Dr. N. Madhusudan Rao, Deputy Director, CCMB, Hyderabad: Member
Dr. C. M. Gupta, Former Director, Central Drug Research Institute, Lucknow: Member
Dr S. B. Dongre, Director (F&VP), Food Safety and Standards Authority (FSSA), New Delhi - (Representative of MoH&FW): Member
Dr. Dhir Singh, ADG (PFA), FSSAI - (Representative of MoH&FW): Member
Dr. K. Satyanarayan, Scientist G, ICMR, New Delhi: Member
Dr. Dharmeshwar Das, Director, Indian Veterinary Research Institute, Izatnagar: Member
Dr. A. K. Srivastava, Director, National Diary Research Institute, Karnal: Member
Dr. Dilip Kumar, Director, Central Institute of Fisheries Education, Mumbai: Member
Dr. Mathura Rai, Director, Indian Institute of Vegetable Research, Varanasi: Member
Dr. P. Anand Kumar, Project Director, NRCPB, IARI, New Delhi: Member
Dr. K. K. Tripathi, Adviser, DBT, New Delhi: Member
Dr R Warrier, Director and MS GEAC: Convener

A re-look at the EC2

Prof Arjula Reddy, the Chair of the Committee:
In a phone conversation to Dr Pushpa Bhargava, Prof Reddy is supposed to have told Dr Bhargava, sometime in the first week of October (?):

- that eight of the tests that Dr Bhargava said should be done on Bt Brinjal and with which Prof Reddy agreed, had not been done;
- that even in the case of tests that have been done, many have not been done satisfactorily and adequately;
- that he (Prof Reddy) was under ‘tremendous pressure’ to clear Bt Brinjal and had calls from ‘Agriculture Minister, GEAC and industry’.

Attached is a note/affidavit from Dr Bhargava on this matter (Annexure 2). Prof Reddy has also been quoted in a Tehelka article on Bt Brinjal recently in the following manner:

When asked if there was any proof Bt brinjal was safe, he replied, “What we require is long-range research done over many years. That does not exist (for Bt brinjal).” Then why give the clearance if the required research is absent? “All the approved protocols by the government has been fulfilled by the developers and the public institutions [that participated in the safety assessment].”

Source: Uber Gene, Tehelka Magazine, Vol 6, Issue 44, Dated November 07, 2009 at
http://www.tehelka.com/story_main43.asp?
filename=Ne071109uber_gene.asp

However, these views are not reflected in the final report of the EC2, indicating that Prof Reddy succumbed to pressure.

2. Dr K K Tripathi, Review Committee on Genetic Manipulation, Dept of Biotechnology.

A complaint is pending against Dr K K Tripathi with the Central Vigilance Commission (CVC) (complaint dated 6/6/09 from Nuziveedu Seeds, and Central Vigilance Commission Complaint No. 780/09/6, being examined in the Commission Annexure 3), for “abuse of power”. This complaint, filed by Nuziveedu Seeds Ltd, points out that Dr Tripathi has been exercising undue discretionary powers to promote interests of certain companies of his choice (Mahyco specifically) and harm others. The CVC complaint lodged points out the following:

“The RCGM, MEC and GEAC are independent committees meant to act as checks and balance for each other and prevent any one individual from influencing their decision. However, the presence of one person (Dr. K K Tripathi) on all three committees and in the capacity of Member Secretary on two key committees besides his administrative powers as Advisor DBT, has given him a chance to manipulate the decisions in these committees to further his vested agenda by misinforming and misrepresenting facts in these committees”.

Dr Tripathi was also part of the EC2! It violates any principle of fair inquiry to have him in this committee when investigations are pending against a complaint for his excessive favouring of Mahyco when the EC2 was considering a Mahyco application for Bt Brinjal commercialization!

Further, Dr Tripathi was the one who signed off on various protocols and permission letters for testing Bt Brinjal’s biosafety and efficacy and obviously thought this was adequate and appropriate, while the Expert Committee was supposed to be reviewing the concerns expressed on these very protocols and studies!

3. Dr Mathura Rai, Director, Indian Institute of Vegetable Research (IIVR)

He/IIVR is part of the ABSP II project (more details in Annexure 4). This project is funded by USAID, which in turn gets funded by Monsanto for certain projects and funds Monsanto for certain other projects. ABSPII is “supporting Mahyco in gaining regulatory approval for the technology””¦ says a project document on the official website (http://www.absp2.cornell.edu).

USAID funding of this project goes expressly into activities like: “Support Mahyco’s efforts to complete regulatory approval”!

Dr Mathura Rai also acted as the lead investigator, so to speak, on the large scale trials of Mahyco’s Bt Brinjal in the past two years. He directly supervised all the trials as recommended by the Expert Committee (EC1 led by Dr Deepak Paintal/Dr C R Babu) and generated findings.

He not only did these studies even though he is part of ABSPII but he also reviewed his own findings by being part of the Expert Committee set up “to review findings from large scale trials and other biosafety tests”! Incidentally, the EC2 itself is called the “Expert Committee to review the findings of Large Scale Trials and other related biosafety studies on Bt Brinjal””¦

4. Dr Ananda Kumar, Project Director, NRCPB, Indian Agricultural Research Institute (IARI), Delhi

Dr Ananda Kumar is a Bt Brinjal developer himself. Given that his own product is in the pipeline of development and commercialization, his inclusion in the Expert Committee once again violates principles of fair inquiry and brings in conflicting interests.

Amongst the 16 members of the Committee, both the above (Dr Mathura Rai and Dr Ananda Kumar) are agriculture scientists and both are involved in Bt Brinjal development and were made part of this Expert Committee!

In the above context, it may be noted that the Expert Committee has denied that India is a Centre of Origin of Brinjal, even though the crop developer also accepts this fact along with other agencies like National Bureau of Plant Genetic Resources!

5. Dr Dilip Kumar, Director, Central Institute of Fisheries Education, Mumbai

The Central Institute of Fisheries Education had taken up a Mahyco-sponsored study on Bt Brinjal and the Director was now sitting in the Expert Committee to review his Institute’s findings amongst other findings!

6. & 7. Dr Vasantha Muthuswamy and Dr B Sesikeran, Director, National Institute of Nutrition.

These two members played a lead role in the recasting of regulatory guidelines for safety assessment of GM foods in India, with the funding of USAID under the South Asia Biosafety Programme (SABP). Dr Muthuswamy is a GEAC member while Dr Sesikeran is an RCGM member.

On the grounds of harmonizing the Indian regulatory regime with Codex Alimentarius guidelines, this exercise not only ignored all the many important tests and procedures being prescribed by Dr Pushpa Bhargava, the Supreme Court observer in the GEAC and others, but threw out many tests that were hitherto being conducted in India.

Incidentally, the ABSPII, (funded by USAID) “works collaboratively with the Program for Biosafety Systems (PBS) and the South Asia Biosafety Program (SABP)1” (funded by USAID). The official website states the following in this context:

"ABSPII will identify and support other USAID initiatives to promote safe and effective agricultural biotechnology in Africa and Asia. For example, successful commercialization of bio-engineered crops will depend upon satisfactory biosafety regulation”.

USAID, meanwhile, states that one of its roles is to “integrate GM into local food systems”.

Also interesting to note is a KIA Board Meeting (5th Board Meeting of Indo-US Knowledge Initiative on Agriculture, the bilateral deal signed along with the Indo-US nuclear deal, to bring in the so-called second green revolution into the country) expressly refers to the fact that “guidelines are being drafted for the safety of GM foods for the Government of India” under a section titled “related activities undertaken by other US agencies”.

Dr Muthuswamy and Dr Sesikeran were key members of the drafting committee for the new guidelines. It is of little surprise then that the EC2 report repeatedly resorts to comments like “as per the recently adopted guidelines, such studies do not form part of safety assessment” or that something is “not required” as per the new guidelines.

Thus, with USAID’s interference through the SABP project, unscientific safety testing guidelines and processes have become the criteria for the safety assessment of Bt Brinjal and GM crops rather than rigorous scientific risk assessment and hazard identification. Further, a scientific evaluation of Bt Brinjal is not about conformity to guidelines (newly adopted or otherwise) even as the EC2 report takes a recourse to this often.

8. & 9. Dr Dhir Singh and Dr S B Dongre, “representatives of the Ministry of Health & Family Welfare”

These two members of the EC2, drawn from the Food Safety and Standards Authority, were expressly designated in the EC2 as “representatives of the Ministry of Health &Family Welfare”. From conversations with the FSSA Chairperson and one of these members, it is gleaned by civil society members that these members carried a brief of being present in the EC2 as “observers” and did not take part in the deliberations.

In effect, this implies that no health-related questions were being asked on behalf of the public by any Health Ministry representative in the Expert Committee!

10. Dr C M Gupta, Former Director, Central Drug Research Institute, Lucknow

Dr Gupta, who is also a GEAC member, did not attend both the meetings of EC2.

11. Dr Ranjini Warrier, Member-Secretary, GEAC &Convenor, EC2

It is to Dr Warrier that various communications were sent by many civil society groups about the constitution and mandate of the Expert Committee, right from February 2009. It is obvious that no notice was paid to the objectionable processes being run and that justified demands from citizens were not taken on board.

EXPERT COMMITTEE &SUBSEQUENT PROCESSES

The Expert Committee met twice, on July 30th and August 31st 2009 reportedly for a few hours each, and came up with its 105-page report. In these two meetings, thousands of pages of biosafety dossiers of Bt Brinjal in addition to independent reviews and other feedback were apparently perused by the Committee for finalizing its report!

The GEAC did not address the issues raised by civil society groups about the constitution and mandate of this Expert Committee.

This is just a portion of the report that I am sharing with you. For a complete version, please write to Kavitha Kuruganti at This email address is being protected from spambots. You need JavaScript enabled to view it.