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Supreme Court and regulatory failure (7/5/2007)

Below are some of the issues that will be coming up before the Indian Supreme Court in the latest round of the Public Interest Litigation brought by Aruna Rodrigues and her co-petitioners.

The failure of Indian regulators to comply either with the order of the Supreme Court or that of Central Information Commission (CIC) to make public the data generated by tests carried out on GM crops, has helped to exemplify the critical issue of whether GMOs are being released without adequate testing and/or without key biosafety data being analysed.

The petitioners will be drawing attention to:

(a) Toxicity and allergenicity: the fact that there are major gaps internationally in safety testing.

In India GMOs are, it now seems clear, being released without safety testing data, at least as regards the vital aspect of toxicity and allergenicity. Evidence of this exists for okra, mustard and rice.

India's regulators have refused to provide the relevant information for Bt brinjal and will be penalised accordingly. It is only a question of time before they will have to comply, but their refusal to date raises the question of what they have to hide.

(b) Conflict of interest: exemplified by CD Mayee, co-chair of India's apex GM regulatory body - the GEAC - and at the same time a director of the biotech industry funded and directed ISAAA which is active - with Mayee's active involvement - in promoting GM in India.

(c) Safety Testing Protocols - the gaps, the fraud and the complexities given that the uncertainties of GM are inhererent in the technology (unintended effects).

The petitioners will be drawing attention to the views on safety testing of international experts like Arpad Pusztai, David Schubert and Gilles Eric Seralini.

This is from the last page of the affidavit.

Says Schubert, "Secondary modifications could be assayed by monitoring of the introduced gene product by mass spectroscopy; changes in gene expression could be assayed by DNA chips; and metabolically active molecules could be measured biochemically". The problem says Schubert is, of course, that, "unless we know exactly what to look for, we are likely to miss the relevant changes.---- However, even extensive animal testing might not detect the consequences of deficiencies in beneficial plant products. GM food is not a safe option, given our current lack of understanding of the consequences of recombinant technology".

The above evidence highlights the laxness that prevails internationally, and in India in current health safety testing in the absence of specified protocols and the degree of rigour and transparency that is required to ensure that safety testing is undertaken according to the evolving best science and practices, which alone will ensure that the public are not guinea pigs in the experiment with GM crops. Other ecological and biosafety aspects, farming economics, farmer rights and development present other complexities and will require much more work to determine their impacts. The warnings of Schubert, Pusztai and Seralini among a host of other scientists must be heeded. In the light of this data, the Regulator’s non-compliance with the Order of this Hon'ble Court of 15th February 2007 is extremely serious and represents a less than transparent response which must be corrected. The Order states: "The Union of India will file a report within six weeks stating therein as to what would be the implications of the biological results of these tests". Therefore, to comply with this Order, the first requirement is for all bio-safety data for every crop that has been field tested and for Bt cotton which has been commercialised, to be published on the Ministry's website for scrutiny by independent experts. Data for allergenicity and toxicity are a particular requirement. The absence of any data will be taken to mean that the required tests have not been conducted. In the meanwhile, it is also required that: the Hon'ble Court may direct the respondents to immediately:

(a) provide a comprehensive list of field trials of GMOs that have been conducted during 2005-2007 with their locations, and with their genetic sequences;

(b) institute a comprehensive and systematic plan in the public domain and with the involvement of civil society for comprehensive, nationwide testing for contamination of farmers' fields and food from Bt cotton and from field trials of various crops;

(c) in the meanwhile, to institute an autonomous panel of Independent scientific and credible experts mandated to protect India’s biodiversity, as Ombudsman, to oversee GM biosafety and GM policy; and

(d) that environmental releases of GMOs will not be permitted till each GMO to be released is cleared by such a panel as above, of independent scientific and credible experts, having first been subjected to a comprehensive, rigorous biosafety test protocol in the public domain as prayed for in the WP and that GM imports are subjected to the same oversight with mandatory labelling of any imports so cleared.

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