GM Free Cymru

BT Brinjal safety assessments were probably fraudulent

Dr Lou Gallagher has undertaken an independent assessment of the safety / toxicology studies submitted by Mahyco to the Indian authorities, which purported to show that the GM eggplants were entirely safe. Her Report shows that the safety claims are not supported by the data. Furthermore, the clear signs of organ and system damage in the group of animals fed on BT brinjal were "airbrushed out" -- and Dr Gallagher clearly suspects that the conclusions to the studies were not written by the original research teams, but by Mahyco, who paid for the studies. She noted that it's not just the conclusions that are at variance -- even the text does not match the experimental data, and the researchers did not personally sign off their reports.

Poor science or corrupt science? We don't need to worry too much about that question -- for many years Monsanto and its associated companies have been falsifying research designed to show the safety of their GM products. And getting away with it, because of the incompetence of the regulators like EFSA and FSANZ who are supposed to subject studies such as this Mahyco dossier to tight scrutiny.

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Quote: "In particular, 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 (elevated eosinophils in particular) indicating immune function changes possibly due to allergen response, and toxic effects to the liver as demonstrated by elevated bilirubin along with plasma acetylcholinesterase."

Quote: "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."

BT BRINJAL Event EE1 The Scope and Adequacy of the GEAC Toxicological Risk Assessment Review of Oral Toxicity Studies in Rats

November 14, 2010 Dr Lou M Gallagher, PhD Wellington, New Zealand

Signs of food toxicity in genetically engineered eggplant (Brinjal) Commercial planting in India currently barred

14 January 2011 Munich, New Delhi

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.

Contact: Lou Gallagher +64 21 662 544, independent.epi@gmail.com Aruna Rodrigues, Sunray Harvesters, arunarod@gmail.com Christoph Then, Testbiotech +49 15154638040, info@testbiotech.org

http://www.testbiotech.de/sites/default/files/Report%20Gallagher_2011.pdf

REPORT CONCLUSIONS

A review of the adequacy of current toxicology studies to address the safety of genetically modified Bt brinjal for commercial release shows that the studies were not conducted according to the published standard, did not accurately summarize results, and ignored toxic endpoints for rats fed Bt brinjal. For a brief period of time (1998 to 2001) there appeared to be an exemption given to genetically modified foods that showed no signs of toxicity: if a food tested at a dose of 1000 mg/kg‐day produced no toxic effects then further testing was not required. According to OECD 1998 (page 3, item 16) and the 1998 DBT protocol quoted here, “If a test at one dose of at least 1000 mg/kg body weight (but expected human exposure may indicate the need for a higher dose level) using the procedures described for this study produces no observable toxic effects, then a full study using 3 dose levels may not be necessary.” Although this apparent exemption is no longer part of GM testing protocol (WHO/FAO 2000, Codex Alimentarius 2003a‐c, EFSA 2008) the 90‐day toxicity study appeared to be conducted at the particular dose of 1000 mg/kg‐day with the expectation of finding no evidence of toxicity. 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. Not only has the scrutiny of these data provided insight into the substandard and extremely misleading interpretation of results, but it suggests to the reviewer that urgent changes need to be made to ensure that future studies are properly conducted and interpreted. In particular, 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 (elevated eosinophils in particular) indicating immune function changes possibly due to allergen response, and toxic effects to the liver as demonstrated by elevated bilirubin along with plasma acetylcholinesterase. Further studies are required to assess the potential outcomes of these indicators of toxicity.

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The raw materials:

Biosafety Data of Bt Brinjal containing cry1Ac (EE1) event developed by M/s Maharashtra Hybrid Seeds Company Limited <http://www.envfor.nic.in/divisions/csurv/geac/bt_brinjal.html>

Additional Data Generated on safety and Efficacy of Bt Brinjal Event EE1(2007-2009) <http://www.envfor.nic.in/divisions/csurv/geac/Bt_Brinjal/ Bt_Brinjal.htm>

http://www.envfor.nic.in

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