Aruna Rogrigues
to
DR.VISHWA MOHAN KATOCH
Secretary to Govt. of India        
Department of Health Research
(Ministry of Health & Family Welfare) &
Director General
Indian Council of Medical Research
Ramalingaswami Bhawan,
Ansari Nagar
New Delhi 110029
10th January 2010


BT BRINJAL: THE ICMR GUIDELINES 2008
&
THE ICMR & MINISTRY OF HEALTH & FAMILY WELFARE REPRESENTATION IN THE Bt BRINJAL EXPERT COMMITTEE II (EC II)

Dear Dr Katoch

I wish to draw your attention to specific matters of significant concern connected with the above subject, in view of their far-reaching implications for GM bio-safety policy in our country. These matters relate in particular, both to the inputs provided to the EC II by scientists representing the Ministry of Health, including the autonomous ICMR, as well as the ICMR bio-safety Guidelines 2008. The approval of Bt brinjal for commercial release by the GEAC accepting the EC II Report on the 14th Oct 2009 was impacted by both these factors.

1. Representation, Attendance at & The Inherent Conflict of Interest in the Members of the Bt Brinjal EC II

i. Dr Dhir Singh and Dr SB Dongre, were both members of the ECII, drawn from the Food Safety and Standards Authority. They were expressly nominated to the ECII as “representatives of the Ministry of Health and Family Welfare”. On close enquiry, it would seem that neither member took an active part in the proceedings of the EC II, being apparently designated ‘observers’. It is on record that they attended the second of a total of two meetings of the ECII and we believe, provided no inputs into the deliberations.

ii. Dr K Satyanarayana of the ICMR attended only the first meeting of the ECII. Dr Satyanarayana is part of the RCGM, the GEAC as well as the EC2.
iii. Dr Vasantha Muthuswamy of the ICMR and Dr B Sesikeran, Director, National Institute of Nutrition had key roles in drafting the ICMR bio-safety guidelines for GM crops. The former is also a GEAC member while the latter is an RCGM member.
The above evidence shows paltry attendance. Therefore, the lack of serious application by the M of H & FW and the ICMR on a matter of vital importance to the national interest, is unquestionably startling. If it is also true, that both Drs. Dhir Singh and Dongre provided no inputs into the EC II, then this too is a significant omission. These acts collectively, effectively deny the citizens of India a national ‘health insurance’ and professional scrutiny against the hazards of GM crops, from the very institution nominated for this task. And we have every right to expect impeccable quality. Furthermore, the facts demonstrate a conspicuous lack of independence in the choice of the ICMR membership of the EC II, even a clear conflict of interest, especially since the ICMR Safety Guidelines underpin the approval of Bt brinjal. What follows below, adds further substance to the criticism that these guidelines lack both rigour and sceptical analyses as a prior position, for the risk assessment and hazard identification of GM crops.  

2. ICMR Bio-safety Guidelines 2008

As recorded in the Supreme Court (SC) evidence of August 2008, and the record of various Meetings of the GEAC in particular the 85th Meeting on 28th May 2008, we have the following statement:

i. “The representative of ICMR was in agreement with the views expressed by Dr. Bhargava on the chronic toxicity issue especially in GM foods which are to be used for long periods by human beings”, (reference point 5.7 of Agenda item 4).

The matter under discussion was the essential requirement to test GM foods for chronic toxicity, which therefore require long term testing.  

ii. It was further agreed, that therefore, the ICMR bio-safety guide lines would be amended and that Dr Vasantha Muthswamy would interact with Dr Bhargava to prepare another draft (item 4.2 of the 85th Meeting).

In the event and contrary to the above needed alterations,  the ICMR guidelines were ‘quietly’ finalised without any change to the draft, sometime in 2008, and without further comment at any subsequent GEAC Meeting and posted on the Ministry’s website.

These Guidelines have been referenced repeatedly in the ECII Report as being the official accepted benchmark for safety testing standards of GM Crops in the view of the Indian Regulators and claimed to be adhered to by Mahyco-Monsanto for Bt brinjal, which therefore, legitimises their Bt brinjal safety dossier:  
➢ “as per the recently adopted guidelines, such studies do not form part of safety assessment”. (EC II report)
Furthermore, Prof Arjula Reddy, co-chair of the GEAC and Chairman of the EC II,  made the following statement to Tehelka on Bt Brinjal (and a similar statement  to CNN-IBN which was widely televised):
On the safety of Bt brinjal whether it was safe he said:
➢ “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 have been fulfilled by the developers and the public institutions [that participated in the safety assessment].”

What we have here is a circular argument, more accurately, chicanery in a government body in charge of perhaps the most critical assessment of any process and technology that will impact India with irreversible consequences. And regrettably, the ICMR guidelines aid and abet this process and in a representation on the EC II that is inappropriate. It may be noted that Bt brinjal fails even the ICMR’s guidelines for allergenicity. It is surprising that this was not objected to.

In November ’08, the Union of India in its submission to the SC objected to tests for chronic toxicity on the grounds that they would take too long, also for other tests for unintended effects like proteomics, which were declared too expensive and impractical because they were not available. The questions of course are, too long and too expensive for whom? And whose advantage are the Regulators pushing? We now have a different explanation in the EC II Report based on the fact that these tests are not mentioned in the ICMR guidelines and therefore, not required.

The ICMR safety guidelines serve as minimal guidelines and are flawed in many aspects because of this. The fact is that they are also a dilution of even previously inadequate bio-safety regulation. The most glaring omission is the absence of tests for chronic toxicity. The methods of rigorous bio-safety and risk assessment in their time-scale are by definition, long term, to uncover the potential harmful changes in GE proteins in foods as a result of the transformation process. Many of the animal feeding studies in the last 12 months undertaken by independent scientists have uncovered toxic effects in approved GM crops through long term, life time and multigenerational animal feeding studies: also, thorough up-to-date methods of genomic analyses. Yet the Regulators in their Reply in the SC are on record dismissing both, scientific methods of risk assessment and hazard identification to uncover the unique risks of GM crops, on the inexcusable and flimsy grounds that they will take too long. The ICMR safety guidelines support an already deeply flawed regulatory process, and the Regulators have willingly adopted them as the official benchmark for the bio-safety of GM crops.

In view of these substantiated facts, I respectfully request you to withdraw the 2008 ‘ICMR Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants’ in the interest of our Nation’s health and bio-safety. I also take this opportunity to enclose the following documents from eminent scientists, which have been submitted to the Minister, Jairam Ramesh in response to the EC II Report:

Ӣ Prof. Dave Schubert: on the toxicity of the Bt protein
Ӣ Prof Jack Heinemann: Documents 1 & 2 on molecular characterisation and genomic analyses
Ӣ Arpad Pusztai: A search of the scientific literature of evidence of the toxicity of the Bt gene: (2007 Submission to the SC)

Thank you

With kind regards
Yours sincerely

Aruna Rodrigues

References:
i.    Minutes of the 85th Meeting of the GEAC dated 28th May, 2008
ii.    Minutes of the 83rd Meeting of the GEAC dated 2nd April,2008,
iii.    Minutes of the 91st Meeting of the GEAC
iv.    Dr. Bhargava’s responses  to the Member Secy. GEAC (Annexure B4 Colly. of the Supreme Court Evidence of Aug 08).
v.    ‘Is This What Indians Should be Trusting’: research and compilation by Kavitha Kuruganti submitted to the Minister, E & F
vi.    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
vii.    Supreme Court Submission of August 08