PRESS RELEASE: BT BRINJAL

PROF G-E SERALINI, IN HIS INDEPENDENT SCIENTIFIC APPRAISAL OF MAHYCO-MONSANTO'S BT BRINJAL FEEDING STUDIES, SAYS: "BT BRINJAL MAY PRESENT A SERIOUS RISK FOR HUMAN AND ANIMAL HEALTH & THE RELEASE SHOULD BE FORBIDDEN".

* His critique of Mahyco's dossier confirms the mounting evidence against India's Apex Regulator (the GEAC) in the Supreme Court that it acts to support the 'Industry', mortgaging the Nation's health, food security and biodiversity. These potential impacts will be irreversible if Bt Brinjal is commercialised.
*Since it is civil society that is now bearing and will in future bear the brunt in perpetuity of the Regulators' reckless rush to commercialise this technology in India in partnership with the US Government and Monsanto, how we proceed is of the uttermost national importance. It therefore requires the most serious application of wills and hearts of National Government and civil society to ensure that India gets it right, NOW, for we will not get a second chance.

In August 2008, after a protracted 2 year battle and a Supreme Court Order in the PIL by lead petitioner Aruna Rodrigues and Co-Petitioners R Baruah, PV Satheesh and D Sharma, the GEAC published the Mahyco-Monsanto test dossier on Bt Brinjal and placed it in the public domain on the Ministry of Environment & Forests website. In the meanwhile, however, the GEAC permitted pre-commercial large-scale field trials of transgenic (Bt) brinjal in blatant Contempt of Court. Brinjal is a ‘favourite’ and important vegetable in India and it has a major presence on the ‘dinner plate’ of the urban and rural, rich and poor. Brinjal is known to have existed in India for 4000 years. Given that India is also a functional Centre of Origin of brinjal, any release of Bt Brinjal into the environment, poses a significant risk of contamination to sexually compatible wild species and consequent harm to biodiversity, in addition to the contamination of Non-GM varieties.

Prof. Gilles-Eric Seralini was commissioned by GreenPeace India to appraise the Mahyco studies in a qualitative assessment of them. The Seralini Bt Brinjal Appraisal covers (a) health impacts and (b) environment studies, in particular, gene flow as the route to environmental contamination, as well as impacts on ‘target’ (the pest that it is directed at) and ‘non-target’ organisms (other organisms). 3 issues need to be highlighted right away which invalidate Mahyco's studies:

Good laboratory practice has been seriously flouted because (a) reference materials have not been checked by the receiving lab for their authenticity (b) most of the laboratory tests are unsigned by the researchers who have performed the tests (signature frames are empty); (c) the other surprising discovery of importance is that whereas  Bt brinjal has always been referred to in every regulatory document as Cry1Ac (a protein), it now transpires as a result of Seralini's scrutiny of its molecular characteristics that this Bt brinjal is in reality a chimeric transgene (hybrid or fusion gene) that has been modified "to produce an unknown chimeric insecticide toxin containing Cry1Ab and Cry1Ac modified sequences".  Furthermore, in the “toxicity tests on target and non-target insects, this chimeric toxin has not been used but instead, an improper Cry1Ac toxin (was used) because this control was easier”.

The main points:

Health
a.    Bt brinjal produces a protein in the vegetable cells, inducing resistance towards at least kanamycin, a well known antibiotic. This is typical of first generation GMOs, which were engineered without consideration of the problem. Antibiotic resistance is recognized to be a major health problem because of the growing development of antibiotic resistance genes. It is very inappropriate to consider commercialising a food containing an antibiotic resistance gene, since several modern biotechnology companies have already developed transgenic plants without these marker genes. "It is possible that Mahyco has bought an old unused GMO technology to Monsanto Company”.

b.    Bt brinjal has not been properly tested for health or environmental safety.  In feeding trials, numerous significant differences were noted compared to the best corresponding non-Bt controls: Bt brinjal appears to contain 15% less kcal/100 g, has a different alkaloïd content, and 16-17 mg/kg Bt insecticide toxin poorly characterized for side effects, and produced by the plant genetically modified for this. In animals fed this GMO, several parameters were effected including blood cells or chemistry, with significant differences according to the period of measurement during the study or the sex of the animal. These include prothrombin (blood clotting) time, biochemical parameters such as total bilirubin (an indicator of liver health). Alkaline phosphatase was also changed, as well as feed consumption and weight gain; milk production in cows was 10- 14% higher. There was more milk and more roughage dry matter intake as if the animals were treated by a hormone. Rats GM-fed had
diarrhoea, higher water consumption, liver weight decrease as well as relative liver to body weight ratio decrease.
    Please see 'summary' for more detail.

c.    These differences are frequently unreported in the summaries of the different experiments but are 'visible' in the raw data. These differences were, when discussed, disregarded, on a number of grounds, principally on the grounds that they were within the range of a wide “reference” group (really larger than the real closest control group). This reference group represents a wide range of brinjal types and is not a strict comparison.  Such declarations that the differences seen are not of biological relevance are not substantiated by the data presented in the feeding trials. Clear significant differences were seen that raise food safety concerns and warrant further investigation.

"This makes for a very coherent picture of Bt brinjal that is potentially unsafe for human consumption. “---It will be also be potentially unsafe to eat animals with these problems that have been fed GMOs. The GM Bt brinjal cannot be considered as safe as its non GM counterpart. Indeed, it should be considered as unsuitable for human and animal consumption. In addition, the longest toxicity tests which are for only 90 days do not assess long-term effects like the development of tumours or cancers".

Environmental
a.    Non-target Organisms: It is a very serious matter that studies directed at impacts on Non-Target Organisms are perfunctory and effectively absent. Seralini states: “it is almost impossible through measurements of toxicity to a few species of non-target organisms to get a sufficient view of possible harm to complicated ecosystems, which moreover vary substantially from place to place in India. The experiments on the potential toxicity of GM Bt brinjal to non target organisms (such as butterflies and moths), to beneficial insects and to long-term soil health are woefully inadequate and give no assurances for the environmental safety of growing GM Bt brinjal. Indeed, in many cases the experiments were considered irrelevant (e.g. do not take indirect effects, such as effects up the food chain into account)”.

b.    The gene flow studies are inadequate particularly with regard to the possibility of GM contaminations to neighbouring brinjal crops.
 
c.    The studies neglect other routes of proven contamination (e.g. seed mixing), human error etc.

“Based on these tests, Bt brinjal cannot be considered as ‘safe’. It is known anyway that natural Bt toxins have never been authorised for mammalian consumption. Artificial ones should not be either, before a more serious assessment. Significant effects in comparison to controls are also noticed with other GMOs tolerant to Roundup, and in total with at least four GMOs for which these kinds of tests have been done. These resemble
classical side effects of pesticides in toxicology; and these have also been observed for MON810 maize producing a related insecticide which is present in part in the Bt brinjal, Cry1Ab”.---“The agreement for Bt brinjal release into the environment, for food, feed or cultures, may present a serious risk for human and animal health and the release should be forbidden”.

Prof Seralini’s expertise in this field is widely acknowledged. For 9 years, from 1998-2007 he was a member of two Commissions for evaluating GMOs before and after commercial release,  (the Commissions of the French Ministry of Agriculture and Ministry of Ecology). In particular, Mon 810 a Bt corn was found to be toxic after it had been approved for release by EFSA (European Food Safety Authority), as a result of which, it is now banned in France and is under serious review by other EU countries. He was also an ‘Expert’ witness for the EU on their first panel in the WTO conflict with the US on a GM moratorium (2003); ‘Expert’ also for the European Committee for the Reassessment of Biotechnologies (2008). His expertise as a renowned toxicologist and author is acknowledged. He undertakes specialist research on the effects of pesticides on health.

Aruna Rodrigues
(Lead Petitioner, in the PIL to the Supreme Court for a moratorium on GMOs in India)
9th January, 2009