66. Page 48: Goats study sub-chronic 90 days study “It was concluded based on the health, growth and physio-pathological parameters analysed during the experiment that there were no significant differences between the groups fed with Bt brinjal containing cry1Ac gene and control non-Bt brinjal fruit”, says the EC2 yet again. However, the conclusions from the study are different and interpretations highly questionable (like above). Report of Study No. 4417/05 (page 17 of 131), contained in Vol. 4 of the Biosafety Dossier of Bt Brinjal on the GEAC website has the following: “There was significant difference in the hay consumption of the transgenic Bt Brinjal and control non-Bt Brinjal fed groups and the control normal diet group except for incidence of lower hay consumption in G3 group males as compared to G2 group during week 11. The change is considered to be marginal and considered to be of no physiological significance”!

Haemotology: “There was no significant difference in the haemotological parameters between the transgenic Bt Brinjal and control non-Bt Brinjal fed groups except for incidental change in the value of prothrombin in G3 group males at termination”. The prothrombin time for G3 group was 21.47 seconds with the difference with control groups being statistically significant but justified as being within the range of historical control values (prothrombin time 11.8 and 21.6 seconds). The results could easily have been OUTSIDE this range and one can only guess how the crop developer would have justified the statistically significant changes even in this case.

Clinical chemistry parameters: “There were no significant differences in the clinical chemistry parameters between transgenic Bt Brinjal and control non-Bt Brinjal fed groups except for incidental changes in the values of total bilirubin and alkaline phosphatase in G3 group males at termination”.

67. In fact, the EC1 on page 12 of its report refers to mentions that “Two kg of fresh Bt brinjal was considered by the independent testing institution, GB Pant University of Agriculture and Technology, to be appropriate”. This is however not reflected in the protocols.

68. Page 49 Conclusions: The EC2 conclusion on “lack of toxicity in animal feeding studies” is questionable since the data is actually showing findings that require further investigation if not an outright rejection of Bt Brinjal!

69. Page 49 conclusion: “The detailed compositional analysis confirms that Bt brinjal is substantially equivalent to its non-Bt counterpart, as no significant differences were observed in any of the components”. This is questionable since no qualitative compositional analysis has been taken up in the first instance.

70. Page 51: Table 4.1: field trials conducted with Bt Brinjal in India This table has incorrect information on three Mahyco Bt Brinjal hybrids having undergone MLRTs with ICAR in 2006-07. The date of transplanting is not normal and might not have captured peak pest load on the crop.

71. Page 52: Point 4.2.1.: Efficacy of the intended Trait: The results are presented through simple averages and standard deviation. No statistical analysis beyond this was done. Further, the fruit yield in Bt Brinjal is reported to be 335.69 q/ha (+/- 39.36 q/ha) and for non-Bt Brinjal, it is reported to be 287.28 a/ha (+/-28.93 q/ha). However, there are several practicing farmers and scientists who are reporting that their normal yields are in the range of what is being reported for Bt Brinjal! This brings to the fore a question being asked repeatedly where is the need for Bt Brinjal?

72. Page 52: Efficacy of intended trait: Fruit damage in bt hybrids “The cumulative fruit damage during these trials in Bt brinjal hybrids, their non-Bt counterparts and checks was 8.15%, 26.10% and 25.02% respectively. “The mean cumulative fruit damage in Bt hybrids ranged from 6.28% to 10.04%, whereas the range for non-Bt hybrids and checks was 23.52% to 30.36%”, reports the EC2. If that is the case, the yield difference if at all should be only around 16.5% to 20%?? However, the next point on Agronomic Performance records this: “The mean increase in marketable yield of Bt hybrids over their non-Bt counterparts and checks was 71% and 97%, respectively”.

73. Page 52: Economics of Bt Brinjal The pesticides cost projections are based on ETLs and chemical spray recommendations. The numbers projected here are very unscientific since if the same trial was done with different pest management options, including nonchemical IPM and NPM, the economics would be vastly different!

74. Page 53: Estimated economic benefit due to increased marketable yield: on what basis was this calculated? Which year’s price and why? Does this take into account a glut in the market?

75. Page 55: Antibiotic resistance: Reviews by regulatory authorities worldwide will not be readily applicable here one, because of antibiotic resistance as a prevalent problem that health workers are already contending with in India, as compared to situation in other countries; two, consumption patterns of food being different in India where highly processed foods are not consumed and in the case of Bt Brinjal, it could be consumed in numerous ways that are more or less involve direct consumption.

76. Antibiotic resistance: the issue is not that of these nptII and aad genes making antibiotics ineffective because of the enzyme that they produce being in low quantities from Bt Brinjal but that of horizontal gene transfer. Without even studying such a transfer in the case of Bt Brinjal, how can any conclusions be drawn, based on what studies?

77. Page 56: Claim that crops containing antibiotic resistant genes have a history of safe use for more than two decades The EC2 has to show scientific proof of “history of safe use” before claiming so. Which studies have shown this? How do we know that the various problems that let us say the Americans are experiencing, are not in some way linked to GM foods?

78. Page 56: “Point 5.2. Environmental Safety” Centre of Origin issue is yet to be resolved, says EC2. However, authorities concerned about plant biodiversity in the country are not questioning the existing knowledge around Centre of Origin and seem to have firm evidence on India being the Centre of Origin for Brinjal. This issue needs to be resolved scientifically and not just cursorily by an EC2 with two agriculture scientists in it who are both Bt Brinjal developers. The concern in any case is that of our existing diversity being impacted by Bt Brinjal and there are no contentions on the fact that India is a Centre of Diversity for brinjal.

79. Gene flow to wild relatives: this cannot be ruled out not from existing evidence and not from IIVR’s study either. Also, the studies done with such crossability studies left out some species which have shown themselves compatible in other studies (for example, in TNAU).

80. The impacts of contamination cannot be measured only in terms of Cry1Ac trait conferring advantage to the wild relatives”¦.Will there be no other changes with the gene transfer occurring? Is there scientific evidence for this that no other changes are to be expected? Also, is it true that no lepidopteran pests occur on the wild species? Amongst the related species, S incanum is known to have higher FSB infestation than others and is not devoid of pest infestation as stated by the EC2.

81. Issue 4: Effect on Non-target Organisms: Only the EC2 was privy to additional data. Data has been put out in public domain only later and this is being studied.

82. Page 58: Cooking studies (Point 5.3. Food/Feed Safety): This does not address the fact that further metabolites have not been tested for and that there could be other forms of consumption of Bt Brinjal, which do not require cooking. The response also looks at Cry1Ac. This also does not explore whether the harm from a GM food like Bt Brinjal limited to Cry1Ac or newer unpredictable proteins too?

83. Page 58: No long term assessment of chronic effects The need for long term studies has been discounted on faulty grounds. The EC2, as in many other places in the report, talks of Cry1Ac being safe; however, the protein and gene in Bt Brinjal is not Cry1Ac, to begin with. There is NO history of safe use of Bt proteins either. Further, 90 days of a rat’s age is just 3 months out of 36 months, which is 1/12th of its lifetime. This
certainly cannot be equal to 21-25 years of human life. Finally, many chronic health effects that we know today from various contaminants, have not been captured in acute effects’ assessments and there is a lesson to be learnt there.

84. Issue 9, Page 59: Differences found in toxicity studies that have been ignored The argument that if the values and data are within normal physiological range, that the product is still safe is questionable. “In the animal feeding studies conducted with Bt brinjal, no statistically significant changes have been observed in the parameters tested” is an outright false statement. A latest scientific study (Spiroux et al, 2009) elaborates on what is wrong with the current analysis and interpretation with results from toxicity tests and that should be read as a response to the EC2’s comments on this aspect (Annexure 8 “A comparison of the effects of three GM Corn varieties on mammalian health”, 2009). Points 64 and 65 in this note have already addressed the issue of how EC2 is discounting statistically significant differences, even though the crop developer’s data and reports contain the same.

85. Point 5.4. OTHER ISSUES - “Issue No. 10 Impact on Organic Farming” the EC2’s lack of knowledge on the subject is showing starkly. Pest management does not rely totally on botanical extracts in Organic Farming as the EC2 seems to think. Even within that limited understanding, we can show an equal number of studies which show efficacy of organic methods too whose word should prevail? Therefore, this whole section does not merit any response. Further, the callous response towards organic farmers who wish to remain organic is unacceptable. Why should the onus be on them when the problem is arising from somewhere else?

86. Issue 11: Acceptance of data submitted by Mahyco ECI has already made a point on how some of the labs are not NABL accredited labs. There is no reason why the EC2 should go back on that point, given that at least four members, Dr Sesikeran, Dr Anand Kumar, Dr Mathura Rai and Dr Ranjini Warrier were common to both Expert Committees (25% of the members). In fact, Dr Sesikeran had written to the GEAC questioning the lack of authentification of test material, before the actual experiments were taken up. Samples being archived or not archived cannot be verified now.

87. Issue 12: Adequacy of information/data generated by Mahyco: Page 61 The response of the EC2 is completely unscientific and inadequate in this context. While on the one hand, India is supposed to have a case-by-case approval system, this response indicates that Bt Brinjal is not being decided on its own merit but on a pre-decided unscientific notion about Biotechnology, for public sector institutions in particular. The EC2 seems to have forgotten that biotechnology is not just transgenics and not symbolized by Bt Brinjal either. The EC2 should appreciate that this evaluation is not about biotechnology and its need in India but about Bt Brinjal and its safety.

Information obtained under Right To Information shows that the NIN Director sent some comments to GEAC on October 4th 2007. He looked at only three studies: 90 days oral toxicity study (18 different comments but no specific recommendations), Acute Oral Toxicity Test (13 comments) and Allergenicity study (3 comments, on the Rallis study).
For all the three studies, one of the things he pointed out was that characterization/authentification of the test article provided by the sponsor did not happen. This is obviously something that cannot be retro-fitted into the tests that have already taken place and it is surprising that the EC2, which has the same NIN Director as a Member did not make any mention of his earlier findings and observations while addressing this Issue 12 or anywhere else!

88. Section VI: Page 62 Conclusions and Recommendations “Chronic toxicity studies are warranted only if any toxic effects are observed in acute or sub-chronic studies. Since no toxic effects were seen in acute and sub-chronic studies, there is no need and justification for any chronic or long term studies for evaluating the safety of Bt brinjal event EE-1” this is a faulty and unscientific argument. Chronic effects need not show up in acute studies.