India is the world's second leading producer of brinjal (eggplant), a species which originated there. In 2008, the Indian government approved the production of brinjal genetically modified to internally produce bacillus thuringiensis, or Bt, which kills insects. Bt cotton has already been widely commercialized in India, but this would be country's first commercialized GM food crop. The applicants, Monsanto and Indian biotech company Mahyco, conducted safety studies on the Bt brinjal, and while the regulating agencies accepted the results of those studies, independent scientists and activists have sharply criticized them as severely deficient. This article's author and others have petitioned India's Supreme Court to halt the release of Bt brinjal.
The pressing need for an overhaul of GM foods regulation in India was made clear when India's governmental regulators accepted the conclusions of Mahyco-Monsanto's safety studies of its own Bt brinjal without subjecting the studies to independent scrutiny or oversight or separate tests not funded and carried out by the product's own producers.
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 attempts to keep the studies secret by claiming them as "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 Genetic Engineering Approval Committee (GEAC) and Review Committee on Genetic Modification, who appear to be incapable of conducting a proper safety assessment of Bt brinjal, and therefore possibly of any GM crop.
Independent scientists have examined the studies, and their 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; and sample sizes which make sheer mockery of good biosafety testing, among other things. The Mahyco-Monsanto studies are a Gold Standard for how bio-safety testing ought not to be conducted.
In short, the studies 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 intent to mislead, even cover-up and fraud.
There is no scientific basis for the industry claim that Bt crops are safe to eat. Furthermore, to base such a claim on apparent evidence of the success of Bt cotton misses the point - particularly, that cotton is not a food crop, and that Bt 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 of the Cry protein expressed in kernels than would ever result from use of topical Bt toxin as a pesticide. Now, study after study by independent scientists, especially in the last two years, is producing evidence of the toxicity of the Bt transgene and the transgenic Bt plants.
Two eminently qualified independent scientists, Judy Carman and Gilles-Eric Seralini are two eminently qualified independent scientists, who 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 that "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 U.S.-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 center of megadiversity like India. Thus, having received 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 center of origin for rice), are the litmus test of the culpability of the Indian Regulator, who which is now being asked to stand down.
India is one of the world's most biodiverse countries and a 'center of origin' of many plants, the wild species of which have important traits for drought or insect resistance etc., (the same plant traits that biotechnology companies must rely on to produce their GMOs). India is also a center of domestication for many of these plants, and existing domesticated varieties that have been bred over hundreds or thousands of years are, properly, a part of farmers' capital. Transgenic crops, due to the inevitable threat of contamination, threaten biodiversity of both wild and domesticated varieties. Extreme caution should be required before India is exposed to GM crops - and especially a food crop like brinjal, for which India is a centerre of origin and diversity, and for rice, for which India is the center of origin.
No GM crop has been commercialized anywhere in the world in a country that is the center of origin for that crop. That the GEAC, That India's premier rRegulator, the GEAC, sees fit to pay scant attention to such a critical issue defines its their approach and itstheir culpability. I shall return to this point.
On the other hand, Mahyco-Monsanto has done exactly what was expected of them: to put their Bt brinjal in the best possible light by any available means. They have managed this thanks largely to the lack of obstacles in their way - particularly 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 include an admission of the inadequate design of Mahyco's safety studies.
The flaws and gaps in safety testing are significant and serious in the Bt brinjal dossier. With regard to environmental studies, the woefully inadequate gene flow studies and the lack of testing for non-target organisms, soil toxicity and other routes to contamination is a disgrace. Furthermore, Mahyco should have been required by the rRegulators to undertake long-term, multi-generational feeding studies on a large number of animals (e.g. at least 50 rats per group), using species that are proper proxies for humans and to measure outcomes that are relevant to human health (such as full haematology and blood biochemistry and histology on all rats). Such studies should also be designed well enough to stand a chance of determining whether GM brinjal causes any adverse effects on the animals.
Mahyco should also have been required to fully analyze the data and to properly report the findings of the study according to internationally accepted scientific standards (e.g. 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 studies 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 suggests serious incompetence on the regulator's part, or (ii) did understand that the information was inadequate but still passed it as adequate, which invites a charge of criminal negligence.
The GEAC is on record as wanting to "trust" the crop's developers because it would be wrong not to do so without reason - despite Monsanto's history of corporate criminality, including court indictments for some shocking violations. This history includes the production of Agent Orange, dioxin, and PCBs - all of which they declared as safe.
Other examples of Monsanto's business ethics hardly paint the corporations as trustworthy. According to the U.S. Securities & Exchange Commission, Monsanto bribed at least 140 Indonesian officials or their families. 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. Monsanto devotes more than $10 million per year to harassing, intimidating, suing, and in some cases bankrupting American farmers over alleged improper use of its patented seeds.
The urgent question is this: Is India as a nation prepared to risk our entire future for all time, in terms of contamination of our biodiversity, health, 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?
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 commercialization and would have been commercialized by now except for the courageous opposition to it by farmers and civil society groups plus legal opposition.
Dr. Pushpa Bhargava (the Supreme Court's nominee to the GEAC to provide some balance to this committee) has advocated a core list of tests that must be done before any GMO is approved for release. This list has the unqualified agreement of leading international scientists who state that they conform to world class scientific standards for safety assessment. 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. It has been subjected to independent scientific analyses by Seralini and Carman, and even with its severe deficiencies, 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 once introduced into the environment, GMOs can never truly be recalled and thus can have irreversible impacts.
As Dr. Carman has pointed out, if only 1 in 1,000 of exposed people later gets ill, or has an underlying illness made worse, over one million Indians would require treatment. This would result in a huge cost to the Indian government and community.
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. 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. The official GEAC Bt brinjal biosafety dossier is available at www.envfor.nic.in/divisions/csurv/geac/information_brinjal.htm.)
Aruna Rodrigues is spearheading a legal battle in India seeking a moratorium on release of genetically modified crops, a ban on imports of genetically modified products, and setting up an independent testing facility which meets international standards.