NOTE: A must-read critique of Mahyco/Monsanto's safety testing and the laxity of regulation, that has global implications.
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BT BRINJAL IN INDIA: WHY IT MUST NOT BE RELEASED
Aruna Rodrigues
Lead Petitioner to India's Supreme Court
5th January 2009

There is NO scientific basis for the industry claim that Bt crops are safe to eat. Furthermore, to base such a claim on *their* evidence of the success of Bt cotton is to base it more on the fantasies used by the industry to promote their products and profits than  on science - particularly, given that cotton as an animal feed has never been tested for human safety and is seriously implicated in animal toxicity, infertility and deaths.

In nature, bacillus thuringiensis (Bt) kills insects! Bt or the Cry class of proteins are toxic, are not eaten by human beings (or other mammals) and are not declared safe for human consumption.

When the Bt protein is engineered into a plant, that plant produces the toxin internally in grain and other plant tissue. Bt plants are shown to have 1000 times more cry proteins expressed in kernels. Now, study after study by independent scientists, especially in the last two years, is throwing up evidence of the toxicity of the Bt transgene and the whole plant.

Two eminently qualified independent scientists, Judy Carman and Gilles-Eric Seralini, have critiqued the feeding studies of the Mahyco bio-safety dossier of Bt brinjal. Their appraisals represent the first independent scientific scrutiny of any crop developer's safety dossier in India and the first of its kind for a 'near commercialised food crop'. They have stated that Bt brinjal has not been properly and adequately tested by Mahyco, is unsafe and must not be released.

In reply, Mahyco says:

"all its studies followed norms prescribed by GEAC [India's apex GM regulator]. We are at advanced stages of field trial for GM brinjal and our results are extremely promising."

Mahyco is quite right in saying that they have followed norms prescribed by the GEAC. This is exactly the point of the public interest Writ Petition in the Supreme Court of India, that there are no proper bio-safety regulations for the environmental release of transgenic crops in India, with the apex Regulator, the GEAC, essentially adopting US-style lack of regulation for GMOs. 

It gets worse. The Regulators have seriously misled successive Indian Prime Ministers about the truth of GM crops and in particular the inadvisability of introducing these crops in a centre of megadiversity like India, one of 17 worldwide. Thus, having got the political mandate they need, they now function under this mandate openly to promote GMOs without safety testing.

The lack of safety testing is very clear from 4 years of evidence submitted to the court on a whole range of issues including information under the RTI (Right to Information). The Mahyco Bt brinjal dossier of safety studies along with the critical issue of contamination of rice fields as a result of criminally negligent field trials of Bt rice in Jharkhand in July 2008 (in the corridor of THE centre of origin for rice), are the litmus test of the culpability of the Indian Regulator, which is now being asked to stand down.

India and 16 other countries are declared to be centres of megadiversity and are both, 'centres of origin' of many plants with wild species, important traits for drought or insect resistance etc, (the very same plant traits that biotechnology companies must rely on to produce their GMOs), as well as centres of 'domestication' of such plants.

These 'landraces', have evolved over hundreds of years because of farmer inputs and are properly, a part of farmers' capital. Transgenic crops, due to the inevitable contamination they cause, threaten biodiversity.

Extreme caution ought to be required before India is exposed to GM crops and especially to a food crop like brinjal, for which she is a centre of origin and diversity and for rice where she is THE centre of origin.

This is why no GM crop has been commercialised anywhere in the world in a country that is the centre of origin for that crop. That the GEAC, India's apex Regulator sees fit to pay scant attention to such a critical issue defines their approach and their culpability. I shall return to this point.

On the other hand, Mahyco-Monsanto have done exactly what was expected of them: to put their Bt brinjal in the best possible light by whatever means this could be achieved so they could go about their business, which is making profits. They have managed this by means of the lack of obstacles in their way, especially full, stringent and scientifically rigorous regulation. Given the track record of Monsanto's performance in various countries, it can hardly be expected, that the bio-safety dossier of Bt brinjal would say for example, the following:
 
'The Mahyco studies suffer from inadequate study design and sample  size, and in addition we have not conducted some very vital studies, including long term tests to determine  tumours and cancers, tests for unintended effects, tests for non-target organisms. Nevertheless, in spite of  these shortcomings, our studies still demonstrate that our Bt brinjal is unsafe for human and animal health and for the    environment. We are withdrawing our Application for further field trials and commercial release'.

The flaws and gaps in safety testing are significant and serious in the Bt brinjal dossier. With regard to environmental studies, the lack of testing for non-target organisms, soil toxicity and the woefully inadequate gene flow studies, and other routes to contamination, is a total scandal.

Furthermore, Mahyco should have been required by the Regulators to undertake long-term, multi-generational feeding studies on a large number of animals (eg at least 50 rats per group), using species that are proper proxies for humans and to measure outcomes that are relevant to human health (eg full haematology and blood biochemistry and histology on all rats). Such studies should also be designed well enough to stand a chance of determining if GM brinjal causes any adverse effects on the animals.

Mahyco should also have been required  to fully analyse the data and to properly report the findings of the study according to internationally accepted scientific standards (eg to at least report the full nature of each statistical test undertaken and the p-values resulting from the tests). It is of considerable concern that they did not do so. These are studies that were not subjected to any kind of independent scrutiny and oversight, nor did they have the benefit of public-funded safety-testing institutions that are internationally accredited, because we have none.

The inescapable conclusion of these feeding studies is that they have been 'engineered' or designed to throw up 'no significant differences'. It is also clear that the Indian Regulator either (i) did not understand that the information it was given by Mahyco was woefully inadequate, which makes the Regulator incompetent or (ii) did  understand that the information was inadequate, but still passed it as adequate, which therefore, invites the added charge of being criminally negligent.

The appraisals provide evidence of: badly designed studies, fuzzy data masked by too many controls, no 'p' values, a most serious omission, paucity of raw data, no peer review, sample sizes which make sheer mockery of good biosafety testing, among other things.

In all, they are a smokescreen! The study defects are long and would fill a dossier on their own demerits.  It is difficult to avoid the serious conclusion of an intent to mislead, even cover-up and fraud.

It takes great experience and expertise to make 'visible' in raw data, clinical and statistically significant results on various parameters of health, in the blood and in the    cells and organs of animals being tested, as Seralini and Carman have detected. These Mahyco-Monsanto studies are a Gold Standard for how bio-safety testing ought NOT to be conducted.

It has taken two years for these safety studies to be put in the public domain. The Regulator is complicit in having supported the biotech industry and Monsanto, in particular, in their claim of CBI (confidential business information), until forced to change their stance by a Court Order.

Much more serious than Mahyco's 'misdemeanours' is the role of the  Regulators, the GEAC and RCGM, who appear to be incapable of conducting a proper safety assessment of this GM (Bt) crop, and therefore possibly of any GM crop.

The GEAC is on record as wanting to TRUST the crops developers as it would be wrong not to do so without reason! Yet, Monsanto has the history of a corporate criminal, including court indictments for shocking violations. It is responsible for what can only be called crimes against humanity. Its history includes the Anniston "outrage" (the verdict of the court), and the production of agent orange, dioxin, and PCBs - all of which they declared as safe.

Monsanto's business ethics are also reflected in the fact that at least 140 Indonesian officials or their families were bribed, according to the US Securities & Exchange Commission; Dr Margaret Haydon told the Canadian Senate Committee of Monsanto’s 'offer' of a bribe of between $1-2 million to the scientists from Health Canada and how notes and files critical of scientific data provided by Monsanto were stolen from a locked filing cabinet in her office; 10 million dollars per year is devoted to harassing, intimidating, suing and in some cases, bankrupting American farmers over alleged improper use of its patented seeds.

The urgent question is:

Are we as a nation prepared to risk our entire future for all time, in terms of contamination of our biodiversity, health, our farmers & farming environment and food security, because of an inappropriate investment of "trust" by our Government and its Regulator, in Mahyco-Monsanto and other GM crop developers? This is an astounding notion.

Thus, India is at great threat from its own Regulators. The result is that field trials in India have been conducted on every conceivable food crop based mainly on the Bt gene, which is undeniably toxic, over a period of about a decade without proper biosafety tests being done.

The Bt brinjal dossier clearly shows what things have come to. Bt brinjal has not been properly and adequately tested, and is now declared to be un-safe by experts, yet it is on the verge of commercialisation and would have been commercialised by now except for the courageous opposition to it by farmers and civil society groups plus legal opposition.

The core list of tests advocated by Dr Pushpa Bhargava (the Supremem Court's nominee to the GEAC) before any GMO is approved for release, has the unqualified agreement of leading international scientists who state that they conform to world class scientific standards of regulation. These experts have supported the stand that Dr Bhargava has taken in the GEAC despite facing severe opposition from the Regulator that is both unscientific and unprofessional. 

In the ultimate analyses, the Bt brinjal tests quite astoundingly amount to this: 

In the best of the tests, one study of 10 rats, which have been caged for 90 days, has been conducted. Even this study is seriously deficient. It has been subjected to independent scientific analyses by Seralini and Carman and it shows worrying results both clinically and statistically, on various parameters which Mahyco dismiss as not being significant.

Both scientists say the release of Bt brinjal must be forbidden until full and proper safety assessments are done to a proper standard, preferably by researchers who are independent of vested interests, and the results are published in a peer-reviewed scientific journal for other scientists to read and comment upon.

On the best construction of 'intent'  of the GEAC, on the basis of their 'trust' in Mahyco-Monsanto, our  Government and its apex Regulator are prepared to take a risk on the health of one billion Indians, and in perpetuity because GMOs once introduced into the environment can never be recalled and have irreversible impacts.

As Dr Carman has pointed out, if only 1 in 1,000 of those exposed to Bt brinjal later gets ill, or has an underlying illness made worse, then given the size of India's population, the scale of the health consequences and the resulting need for and cost of treatment will be huge. 

This risks a social cost and a health scam of almost unimaginable magnitude that will make 'chicken-feed' of every other scam in the country including the current Satyam scandal. Clearly, the Government of India must be made to see reason in its policy on GM Crops. We must announce a moratorium of at least 5 years, while we get GM regulation on track, in the manner required.

(This analysis is based on evidence provided to the Supreme Court of India)