Archive | November, 2009

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India’s GMO Scandal – Bt Brinjal Approval Rigged By Devinder Sharma

Posted on 30 November 2009 by admin

By Devinder Sharma

30 November, 2009
Devinder Sharma Blog

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 kavitha.kuruganti@gmail.com

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Monsanto Pulls GM Corn Amid Food Safety Concerns

Posted on 17 November 2009 by admin

Monsanto Pulls GM Corn Amid Serious Food Safety Concerns Applicant’s Dossiers Contained Wide-Ranging Fraudulent Research

Press Notice from GM Free Cymru 9 November 2009

For the first time, a GM multinational has pulled two GM corn varieties from the regulatory and assessment process at the eleventh hour (1), after planning for a future income of several billion dollars per year from global sales (2). Monsanto has abandoned its ambitious plans for a so-called “second generation GM crop” rather than accede to a request from European regulators for additional research and safety data (3).

Under conditions of great secrecy, Monsanto has informed EFSA that it no longer wishes to pursue its application for approval of GM maize LY038 and the stacked variety LY038 x MON810. Both of these varieties were designed to accelerate the growth rate of animals. Two letters were sent to EFSA from the Monsanto subsidiary company Renessen at the end of April this year confirming the withdrawal of its applications originally submitted in 2005 and 2006. The letters cite “decreased commercial value worldwide” and state that the high-lysene varieties “will no longer be a part of the Renessen business strategy in the near future.” (4) There has been no announcement of these decisions on the Monsanto web site, and there are no mentions on EFSA or European Commission web sites either. In other words, there is a conspiracy of silence involving both the applicants and the regulators.

The two letters sent to EFSA in April requested the return of all dossier material (varietal characterization, experimental protocols, and test results) which was submitted with the applications for cultivation, animal feed and human food (4). EFSA acceded to this request, making it impossible for any future independent researchers to analyse the Monsanto / Renessen data. That in itself is profoundly disturbing.

Scientists who have followed these two applications are quite convinced that the “decisions to withdraw” have nothing to do with commercial considerations and everything to do with food safety. In other words, the varieties are too dangerous to be allowed onto the open market — although they would certainly have been approved by EFSA and most other European regulatory authorities had it not been for the diligence of independent scientists in New Zealand who subjected the application dossiers to very close scrutiny (5). In the absence of such scrutiny in the United States, the varieties were approved in 2005 for cultivation, animal feed and human food use on the other side of the Atlantic (6). Consents for food and feed use were also given in Japan, Canada, the Philippines, and South Korea. In 2007 Food Standards Australia and New Zealand (FSANZ) approved LY038 for food and feed use in spite of strenuous objections from the Green Party and scientists at Canterbury University’s Centre for Integrated Research in Biosafety (INBI) who warned that the new corn was not safe for humans when cooked (7). They also expressed concerns about unpredictable health effects, increased levels of toxins in high- lysene corn, and possible allergies and links to cancer.
It does not appear that the varieties have been grown or “commercialized” anywhere in the world (8), although test plantings probably occurred in the United States.

“Blatant scientific fraud by the applicants”

While INBI’s detailed and devastating analysis of the applicant’s supporting dossiers was dismissed out of hand by FSANZ, EFSA was forced to take it seriously because of concerns from a large number of European countries including Finland and Malta. The scientific bases of those concerns were highlighted by Jeffrey Smith in his book “Genetic Roulette” and by Prof Jack Heinemann in his book “Hope not Hype” (9). The Monsanto dossiers included rigged research and false assumptions in the reported experiments; a failure to offer any test results based on cooked or processed corn; a failure to test the whole GM plant in feeding trials; confusing and contradictory characterizations of the GM varieties and proteins; a fraudulent mixing of GM strains during trials; a pooling of crop data so as to mask undesirable effects in experiments; feeding trials too short to reveal true physiological changes in animal tissues; and the choice of an irrelevant, unrelated corn variety as the control group for comparison with the GM lines, with the clear intention of hiding potentially serious differences in composition or side effects on animals(10). The Codex guidelines for the testing of GM crops were thus comprehensively broken by Monsanto’s subsidiary Renessen, and were not enforced by the regulators in the USA, Canada, Australia and New Zealand (11). All in all, this amounted to blatant scientific fraud by the applicants, and a cynical failure to enforce the rules, and to protect the public, by the regulators.

During the assessments of these two varieties in Europe, many countries used the INBI peer review of the applicant’s dossiers to underpin their concerns, and these widely-expressed concerns forced EFSA to ask the applicants for additional studies and for a clarification of their experimental data (12). EFSA also asked — for the first time — for adherence to the Codex rules relating to GM and comparator studies. In the knowledge that their dossiers were now being subjected to an unprecedented level of scrutiny, Monsanto / Renessen simply decided that they would not cooperate in this process for fear of what might emerge. So they wrote to EFSA in April (4) to indicate that they were abandoning all plans for the cultivation and commercialization of the two GM crops.

“EFSA has been unfit for purpose”

Commenting for GM-Free Cymru, Dr Brian John said: “This is the first time, to our knowledge, that EFSA has sought to enforce the Codex rules relating to the use of isolines in the testing of GM crops, and the first time that it has expressed profound dissatisfaction about the content of an applicant’s dossiers. It is also the first time that a GM multinational has withdrawn a GM product (or two products) at the eleventh hour. It was insane in the first place to seek to pass GM maize crops containing Bt toxins and “growth enhancers” straight into the human food chain (13). In addition, EFSA and the other regulators have been quite irresponsible in the past in assuming that “stacked” events, hybridized from two GM lines, are harmless if the applicant says so, and if the separate lines have been independently approved. That is simply bad science, since it fails to address the likelihood of synergistic effects and even accumulating toxins in the food chain (14).

“Nonetheless, we applaud the fact that EFSA has asked Monsanto some hard questions in this case, having in the past demonstrated, over and again, that its GMO Panel is simply unfit for purpose (15). This represents progress.

“We are quite convinced that Monsanto has been fully aware, from the beginning, that line LY038 and line LY038 x MON810 are both dangerous; and yet they persisted with their applications until the extent of their scientific fraud was exposed to the public. We should not be surprised by this. The corporation pushes dangerous products onto the food market all the time, and does whatever is necessary to hoodwink the regulators into the belief that all is well (16). We are convinced that Mansanto has other in-house studies which show that these varieties are unstable, unpredictable and harmful to health. Will we ever get to see these studies? No way!”

ENDS

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