1. Bt brinjal confirmed to be toxic
2. Signs of food toxicity in genetically engineered eggplant (Brinjal)

NOTE: Plans for India's first GM crop for human consumption, Bt brinjal (eggplant/aubergine) have triggered a safety report that reveals signs of food toxicity. According to this study prepared independently from industry by Lou Gallagher, environmental epidemiologist and risk assessment expert, there are indications that the consumption of this genetically engineered eggplant (also called brinjal in India) can cause inflammation, reproductive disorders and liver damage.

The report shows why we can't rely on industry tests that purport to show the safety of GMOs and other risky substances.

EXCERPTS from the report by Lou Gallagher:

"Were the contract laboratory INTOX PVT LTD and the funder Mahyco uncomfortable with results showing evident toxicity among rats fed Bt brinjal at 1000 mg/kg/day? Did the researchers write the conclusions for the 14-day and 90-day studies themselves or did others write conclusions for them? These questions are of interest since the text does not match the data, the researchers did not sign their reports, and the cover page of the 90-day report details a completely new report number (R/2183/SOR-90) from that which may be the original, 05.0002."

"...current results from these rat feeding studies indicate that rats eating Bt brinjal experienced organ and system damage: ovaries at half their normal weight, enlarged spleens with white blood cell counts at 35 to 40 percent higher than normal with elevated eosinophils, indicating immune function changes; toxic effects to the liver: as demonstrated by elevated bilirubin and elevated plasma acetylcholinesterase."

Study by Dr. Gallagher: http://www.testbiotech.de/node/444

GMWatch note: We've slightly edited the media releases below for our readers.
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1. BT BRINJAL EVENT EE1 IS CONFIRMED TO BE TOXIC
Aruna Rodrigues, Sunray Harvesters
MEDIA RELEASE
Mhow, 15 January 2011

"A further in-depth analyses of the raw data of Mahyco-Monsanto's Dossier of Bt brinjal, its rat feeding studies, shows Bt brinjal is toxic.  India faces an overwhelming crisis of fraud. The studies are seriously flawed, and wrongly appraised and reported both by Monsanto in its 'dossier' submitted to Government and worse, by our Regulators. The MoE&F [minister of environment and forests] must firmly hold the line on the moratorium and implement his promise of independent testing in internationally certified labs. The Dossier must now be formally rejected by the Indian Government". Aruna Rodrigues

Lou Gallagher, environmental epidemiologist and risk assessment expert, supported by Test Biotech of Munich, analysed the raw data of the 14- and 90-day studies of the Bt brinjal dossier. She confirms in her report:

"current results from these rat feeding studies indicate that rats eating Bt brinjal experienced organ and system damage: ovaries at half their normal weight, enlarged spleens with white blood cell counts at 35 to 40 percent higher than normal with elevated eosinophils, indicating immune function changes; toxic effects to the liver: as demonstrated by elevated bilirubin and elevated plasma acetylcholinesterase."

She states: "Major health problems among test animals were ignored in these reports. The single test dose used was lower than recommended by the Indian protocols. Release of Bt brinjal for human consumption cannot be recommended given the current evidence of toxicity to rats in just 90 days and the studies' serious departures from normal scientific standards".

The study was requested by Aruna Rodrigues to inform Government and the Supreme Court. Gallagher's detailed examination of the raw data of the 'Dossier' follows and confirms the earlier analyses by Seralini, the French expert from Criigen, who similarly reported statistically significant toxic effects in Bt brinjal as compared to the 'controls'. Given the further negative findings from an examination of the dossier by Jack Heinemann (Genomics), Judy Carman (study design and statistical rigour etc) and the authoritative environmental risk assessment by Andow (published), which confirms that the ERA (Environmental Risk Assessment) for Bt brinjal has essentially not been done, then this raises serious questions which must be answered: no official report has addressed concerns raised by these scientists. Not one Indian scientist within the Regulators or our Agri-Institutions has examined the raw data of the dossier. The revised joint report of the 6 Academies of Sciences has similarly defaulted. It therefore, cannot even attempt to respond to the international scientists and has not done so. This second attempt is worse than the first; it confirms corruption through a conflict of interest and/or an ideological mindset at odds with science. It doubles the jeopardy that India faces from such reports. This much is also clear: the comprehensive risk assessment for Bt brinjal has been carried out by independent international scientists of no mean repute. Their substantive analyses cannot be answered in part because our regulators have not analysed the raw data. Why is this being allowed? The scam surrounding GM crops will impact the country with a magnitude like no other scam, if not stemmed now.

The 'Dossier' must be rejected with immediate effect.

Aruna Rodrigues, Sunray Harvesters: This email address is being protected from spambots. You need JavaScript enabled to view it.

More information:
Test Biotech PR enclosed
Study of Dr. Gallagher: http://www.testbiotech.de/node/444
Lou Gallagher +64 21 662 544, This email address is being protected from spambots. You need JavaScript enabled to view it.
Christoph Then, Testbiotech +49 15154638040, This email address is being protected from spambots. You need JavaScript enabled to view it.
Data from Mahyco at: http://www.envfor.nic.in/divisions/csurv/geac/bt_brinjal.html
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2. Signs of food toxicity in genetically engineered eggplant (Brinjal)
Commercial planting in India currently barred
Testbiotech
Media release
Munich, New Delhi, 14 January 2011.

Plans for India's first genetically engineered crop for human consumption have triggered a safety report that reveals signs of food toxicity. According to this study prepared independently from industry, there are serious indications that the consumption of this genetically engineered (Bt) eggplant (also called brinjal in India) can cause inflammation, reproductive disorders and liver damage.

The Monsanto subsidiary, Mahyco, applied for GE eggplant to be commercially grown in India and the Philippines. Eggplant is genetically engineered to produce insecticidal proteins (called Bt toxins) that target certain pests. Brinjal is one of India's most important vegetable crops. The report was requested by Aruna Rodrigues of 'Sunray Harvesters' to inform both India's Government and Supreme Court. In February 2010 India's Minister for Environment & Forests had revoked the approval for genetically engineered eggplant and imposed a moratorium citing the need for independent risk studies. The report evaluates data from feeding studies on rats commissioned by Mahyco to demonstrate the safety of the genetically engineered eggplant.

Lou Gallagher, the epidemiologist from New Zealand who prepared the report says that "The safety claims made for these plants are not supported by existing data. On the contrary, there are alarming signs that the consumption of food derived from these plants could result in adverse health effects. In addition the feedings studies show major deficiencies in the protocol used for the feeding trial and do not meet international standards." Dr. Gallagher concludes that on the basis of the existing data genetically engineered eggplant cannot be recommended for human consumption.

Testbiotech supported the evaluation of the data in cooperation with the GEKKO Foundation. "This independent expert assessment provides a critical counter to the Monsanto sourced analyses, which deny any health safety risks: It exposes deficiencies in the risk assessment that was presented to the Indian government. We must ensure that safety standards are not sacrificed to satisfy commercial interests." says Christoph Then, on behalf of Testbiotech.

More information:
Study of Dr. Gallagher: http://www.testbiotech.de/node/444
Lou Gallagher +64 21 662 544, This email address is being protected from spambots. You need JavaScript enabled to view it.
Aruna Rodrigues, Sunray Harvesters, This email address is being protected from spambots. You need JavaScript enabled to view it.
Christoph Then, Testbiotech +49 15154638040, This email address is being protected from spambots. You need JavaScript enabled to view it.
Data from Mahyco at: http://www.envfor.nic.in/divisions/csurv/geac/bt_brinjal.html
Testbiotech e.V., Institute for Independent Impact Assessment in Biotechnology www.testbiotech.org