RESPONSE TO THE EXPERT COMMITTEE (EC2) ON BT BRINJAL
The following is a response from Kavitha Kuruganti, Kheti Virasat Mission on the EC2 report on Bt Brinjal, as per the call put out by the Hon’ble Minister for Environment & Forests, Govt of India, on October 15th 2009, seeking public feedback.

The responses have been divided into 4 distinct sections as below:
I. ISSUES WITH THE EXPERT COMMITTEE: IS THIS WHAT THE NATION SHOULD BE ASKED TO RESPOND TO?
II. GENERAL RESPONSE TO EC2 REPORT & IMPACT ASSESSMENT OF BT BRINJAL
III. SPECIFIC RESPONSES TO EC2 REPORT
IV. OTHER VERY IMPORTANT AND FUNDAMENTAL ISSUES: These include issues like availability of alternatives, pest management and pesticide-related issues with Brinjal, experiences from Bt Cotton, issues around IPRs and farmers’ rights, around Indian Systems of Medicine, around consumer choices and labeling, around Eventbased approval system and around Liability/Redressal/Remediation regimes.

I. ISSUES WITH THE EXPERT COMMITTEE:
IS THIS WHAT THE NATION SHOULD BE ASKED TO RESPOND TO?

The Expert Committee Chairperson, in at least two media interviews (Tehelka and CNN-IBN), expressed the need for more safety tests and long term studies even though the report does not indicate any such views that he holds. There has been at least one more media report based on interviews with expert committee members (Down to Earth, “How Bt Brinjal was Cleared” http://www.downtoearth.org.in/full6.asp?foldername=20091231&filename=news&sec_id=4&sid=3), which further confirms our understanding of the “rigging” of the EC2 report.

This is apart from whether he came under “tremendous pressure” to approve Bt Brinjal or not! Further, there is the issue of conflicting interest and objectionable presence of several EC2 members in this process. All of this makes it very apparent that the EC2 was designed to approve Bt Brinjal. Attached are two different notes on this matter (Annexure 1 is a note on how the Terms of Reference were changed for the EC2 without any apparent processes and about the objectionable presence of several members in the EC2; Annexure 2 is a letter written by scores of organizations and individuals across India to the Prime Minister of India, seeking the withdrawal of the rigged Expert Committee report).

The original Terms of Reference for the Sub-Committee on Bt Brinjal as per the January 2009 GEAC meeting minutes have been changed quite substantially for the constitution of the EC2. No processes have been run to allow for such changes in the mandate and this in itself makes the EC2 process void.

II. SOME GENERAL RESPONSES TO THE EC2 REPORT

The EC2 report is unscientific in its facts and approach and resolutely determined to clear Bt Brinjal and this is apparent almost throughout the report. Just the fact that 16 scientists have apparently gone through thousands of pages of biosafety data without a single adverse comment is really amazing!

1.0 To point out to a few major problems to highlight this aspect (lack of scientific rigour in EC2), one can point out to the references that the EC2 cites some of these are from 1976 (point 1.2.2 on Page 7), 1982 (point 1.2.7. on Page 10) etc.

2.0 The EC2 outright falsified findings saying that “no statistically significant changes have been observed in the parameters tested” in the Food/Feed Safety tests (Page 59, Point 5.3. and Issue 9 of EC2 report). This is simply not true and the crop developer’s own reports do show that there have been statistically significant changes.

3.0 The EC2 ignores much evidence on Horizontal Gene Transfer when it says on Page 55 under Issue 2 that “It has been well established that the probability of transfer of transgenic from GM plant material to bacteria (including that normally inhabit stomach and intestine) is unlikely because of series of well established barriers”. There are numerous scientific studies that show that HGT is a phenomenon found to occur in several instances and a list of references for such studies is attached (Annexure 3: Horizontal Gene Transfer studies).

4.0 At least four members (that is 25% of the members) of the EC2 were also members of Expert Committee I which put out several recommendations in 2007. For no sound scientific reason proffered, the EC2 concluded that the tests recommended by EC1 are not needed as per the “newly adopted guidelines” in India. It should be remembered that these tests recommended by EC1 were not part of the guidelines present at that time either and the EC1 however saw a merit in recommending certain things. The EC2’s unscientific attitude is reflected in this illustration.

5.0 The statement in the EC report (A1 in table in Annexure 1) on page 66 says: "The cry1Ac gene inserted in Bt brinjal event EE-1 has been constructed by combining the first 1398 nucleotides of the cry1Ab gene (corresponding to amino acids 1 to 466) (Fischhoff et. al., 1987) with nucleotides number 1399 to 3534 of the cry1Ac gene (corresponding to amino acids 467 to 1178). The resultant protein encoded by this gene is 99.4% identical to native Cry1Ac from Bacillus thuringiensis sub sp. kurstaki. This difference of 0.6% is attributed to the difference in presence of one amino acid at position 766 i.e. serine in place of leucine”.

Simple calculations done by molecular biologists show that if indeed the difference between native Cry1Ac and the chimeric gene in Bt Brinjal is 0.6%, then the number of amino acid differences is seven and not one! If the EC2, with its collective scientific capabilities can go wrong on a simple fact like this, it is unclear how it can be trusted to take up a scientific evaluation of the safety of Bt Brinjal!

6.0 The EC2 ignored several other points that were brought up (Annexure 4: Compilation of health-biosafety related issues submitted to the EC2) many points with regard to studies that are needed, problems with protocols of studies that were taken up as well as problems with analysis and interpretations of data generated have been ignored by EC2. It is not clear whether it is because of hasty processes run or whether it is a determined approach to ignore feedback that has been sent to the regulators.

7.0 The EC2 report in many places talks about “history of safe use” (of cry1Ac or antibiotic resistance genes or GM crops like Bt Cotton etc.) without citing any scientific study that concludes that there is indeed a “history of safe use”. On what scientific basis is the EC2 claiming such “history of safe use”?

8.0 It is very apparent from the EC2 report, wherein compliance to guidelines is mentioned and commended at least twenty times in the report, that the EC2 made its main mandate the verification of compliance to guidelines rather than actually scientifically evaluate whether Bt Brinjal is safe. This is unacceptable and is certainly not the mandate given to the EC2 when it was set up. Even as this country is going through a debate on the current regulatory regime and its (in)adequacy, there is no point in an Expert Committee checking on compliance. Several of these members were in fact instrumental in designing the protocols and permitting the crop developer to take up unscientific studies and the very constitution of the EC2 once again came in the way of scientific, independent evaluation of protocols, data generated etc.!

9.0 The EC2 at several places in its report refers to regulatory authorities elsewhere accepting something or the other (page 32, 55, 69, 78 etc.) and invokes the example of USA, Canada, Australia etc. What is apparent is that the EC2 wants to make a note of these regulatory decisions from these countries which have allowed GM crops but ignore the regulatory decisions of many other countries or even the regulatory guidelines from countries like Norway, for example. This is very selective and opportunistic on the part of the EC2.

10.0 While the 85th meeting of the GEAC clearly asks the ICMR representative who concurred with Dr Bhargava on the need for long term tests to look into incorporation of at least three more aspects of assessment (need for extensive DNA fingerprinting and proteomic study; Study of possible interaction with the commonly used drugs (especially pro biotic interferences and Reproductive interference) into guidelines, these are outright rejected in the current analysis by EC2, even though Dr Vasantha Muthuswamy is supposed to have concurred with Dr Bhargava in 2008! She was part of the EC2 too. What has changed in between is unclear.

11.0 The EC2’s assessment of Bt Brinjal relies in many places on some studies on Cry1Ac protein whereas Bt Brinjal has a chimeric protein. The EC2 brings down safety issues to just one or two genes (that too a wrong one) whereas the latest research in this area is pointing to the process of Genetic Engineering itself.

12.0 The EC2 was privy to information from Large Scale Trials and some other studies and this information was not put out in the public domain until November 17th 2009. Procedurally, this does not augur well for transparent evaluation and only raises a finger of suspicion over such hasty and secret functioning.

13.0 Any complacency centred around “Protocols approved by RCGM” is indeed an issue and that is the reason why the constitution of the Expert Committee was being objected to by many civil society groups. If the EC2 members are RCGM members who have earlier cleared various protocols for Mahyco, they would obviously defend these rather than take the scientific points on board. The issue raised by Dr Judy Carman about the size of study and control groups of animals in terms of number of animals being too low, not permitting any statistical significance calculations scientifically possible is a good illustration for this. The EC2 did not respond to this point even though this would make all the difference in what a study might actually throw up.

14.0 Not all studies were done by accredited laboratories and that is what the ECI report also pointed out (Page 17) Advinus Therapeutics, Bangalore is a NABL accredited laboratory. INTOX, Pune is an ISO accredited lab and NIN was asked to do an audit of this lab since it is not a NABL accredited lab. Central Institute of Fisheries Education is not an NABL accredited lab. Rallis India Bangalore is not listed in the NABL directory. Vimta Labs, Central Avian Research Institute, IICT, GB Pant University of Agriculture & Technology etc., also need to be seen if they are NABL-accredited. This is an issue that has been taken cognizance of by the Expert Committee 1. It is not rational that the EC2 members, given the kind of overlap that exists in members between the two committees, ignore this valid point made by EC1, which was in the first instance a concern raised by civil society taken on board.

15.0 The new guidelines in India have been adopted by the regulators, after receiving support from USAID for this recasting of guidelines. It is obvious that American business interests have a stake in the new guidelines adopted in India and the adoption of the principle of substantial equivalence formally for the first time in India through these guidelines is being questioned by many scientists. Checking for compliance with these guidelines reeks of vested and conflicting interests given that USAID played a part in Bt Brinjal development as well as in evolving the new guidelines.

16.0 Event based approval system: It has been pointed out time and again that an eventbased approval system that India had embraced, is unscientific and unsound both from a biosafety point of view as well as from an agronomic point of view with new norms that have been adopted recently. The inter-cultivar variability in the protein expressions and other parameters is reason enough to treat each cultivar as a separate GMO. Further, some of the Bt Brinjal hybrids and the Bt Brinjal varieties from the public sector bodies did not even undergo proper agronomic evaluation even as they are being recommended for release by the EC2 and GEAC. This effectively implies that experimentation will take place at the expense of poor farmers, during the period of commercial cultivation! Bt Cotton has valuable lessons to teach on this front where the trials did not comprehensively address various issues and approvals were given hastily in 2002.

17.0 Backcrossing time and process: Effective and good backcrossing in breeding requires at least 4-5 years even with the use of modern-day techniques like Marker Assisted Backcrossing, coupled with ‘shuttle breeding’ etc. which can speed up the processes a bit. With Bt Brinjal, in the case of Mahyco’s hybrids as well as public sector Bt Brinjal varieties in the ABSPII project, it is apparent that such time required has not been spent on backcrossing. In fact, pollen flow studies were taken up in 2002, when backcrossing programme was initiated, with Mahyco’s Bt Brinjal hybrids! Similarly, while the Material Transfer Agreement with Tamil Nadu Agriculture University was signed in 2005 (between Mahyco and TNAU), the field testing in MLRTs commenced in 2007 itself! This is extremely unscientific and unacceptable this story was earlier apparent with Bt Cotton too and it is only now that scientists are acknowledging that many of the new diseases being seen with Bt Cotton in Vidarbha and other places (lalya disease or bronze wilt etc.) is connected to the original American blood still remaining from the Coker 312 parental line and its particular susceptibilities now affecting Indian farmers. It is found that no regulatory body or Expert Committee has so far looked into this issue in depth and verified this to ensure that farmers don’t end up paying the price for such scientific frauds.

III. SPECIFIC RESPONSES TO EC2 REPORT CONTENT

The following points are responses related to biosafety or lack of it, its assessment as well as a few other issues that arise from certain statements made in the EC2 report which have a relevance to the overall assessment of Bt Brinjal, its need, its implications etc. (beyond biosafety too). Several points being raised in these specific responses are a reflection on the state of the regulatory regime in India.

1. The EC2 says (Page 17) that RCGM’s 40th meeting discussed in detail on April 25th, 2006 the data generated by Mahyco; however, it is apparent from the EC1 recommendations, finalized in 2007 that no detailed analysis of the raw data ever took place. The EC1 in fact had asked the Director of National Institute of Nutrition to go through the raw data and as per information obtained under Right To Information, it is apparent that he had looked at the reports of only three studies rather than all the toxicity and allergenicity studies. It is not apparent that this EC2 has studied the raw data either, as they seem to have ignored differences between Bt and non-Bt Brinjal as reflected in different studies.

2. ECI’s recommendations in July 2007 were put out with at least 25% of the members of EC2 being part of EC1 also. These recommendations include comments on studies done in non-NABL accredited laboratories, about Bt Brinjal having to be compared with other pest management options available etc. etc. It therefore requires strong scientific rationale to be provided if the EC2 is discounting the suggestions made by EC1. This is not apparent in the EC2 report however.

3. Table 1.1: Insecticides recommended for FSB: As per CIBRC website, lindane, cypermethrin, endosulfan, cypermethrin 10%, chlorpyrifos 20% EC, carbaryl and cypermethrin+quinalphos are recommended as per legal registration. Neem seed kernel extract also. The 15 listed in EC2 report are wrong/illegal to be cited and used and if others are recommending these other pesticides, it is not acceptable and requires regulatory action. (http://www.cibrc.nic.in/searchbycropname1.asp).

4. 1.2.6.: Non-target organisms like Parasitoids and predator species getting affected by pesticides used to control FSB While it is good to see studies (even if from 1987) cited on unintended impacts on non-target organisms, it is obvious that pesticides and their registration did not capture such impacts. In such a case, it becomes all the more pertinent to ask what studies have been done to look at Bt Brinjal and these parasitoids and impacts on such parasitoids and predator species?

5. 1.2.7.: Genetic Improvement by conventional techniques: This section too is unscientific and opportunistic, citing a paper from 1982. (a) This ignores that pest management need not be brought down to FSB-tolerant cultivars alone, therefore justifying the entry of Bt Brinjal! (b) In any case, FSB-tolerant cultivars have been evolved/released in the recent past even from Tamil Nadu Agriculture University. (c) Further, this point of the EC2 report ignores that genetic improvement is possiblethrough other techniques too like Marker Assisted Selection. (d) Finally, a paper present on the GEAC website called “Centre of Origin, Inter-relationship, and crossability in Solanum melongena” by Dr Major Singh, IIVR cites De Candolle (1886) and Prain (1903) thus: “While some taxonomists think that S. melongena has not been found wild, others feel that S. insanum Roxb. and S. incanum Linn., which are wild taxa and considered to be distinct species, are really varieties of S. melongena (De Candolle, 1886: Prain, 1903). De Candolle (1886) and Prain (1903) reported that S. incanum and S. insanum are varieties of S. melongena and not distinct species. This view also gets strongly supported from inter-crossability to produce fertile hybrids and coexistence of S. melongena, S.incanum and S.insanum in different habitats”. If that was the case, then the EC2 point 1.2.7. is not strictly true. The regulators need to first collect data on FSB resistant cultivars evolved in various research centres in the past decade or so and it is apparent that the EC2 did not put in this effort.

6. 1.2.8.: Alternate strategies: This section fails to mention that alternatives are available. It conveniently talks about non-sustainability of FSB control in future, ignoring the fact that the same would apply to Bt Brinjal too, sooner or later!

7. 1.2.8.: Alternate strategies: The EC2 report says that adoption of transgenic crops with Cry proteins has given excellent results in maize and cotton and that a ‘similar approach in brinjal is expected to provide substantial benefits to farmers’. The EC2 fails to provide references for making this statement since findings from independent studies show a very mixed picture. It also makes the mistake of equating maize and cotton (a crop where the produce mostly goes into industrial uses and a fibre crop resp.) with Brinjal, an edible crop. Importantly, it fails to recognize latest reports on resistance in these very crops that it claims have given excellent results. (Annexure 5: Tabashnik, 2009 coverage).

8. 1.3. Development of Bt Brinjal by M/S Mahyco: The EC2 conveniently ignores an important point being made by independent analysts and others that the gene used in bt Brinjal is NOT cry1Ac. The fact that it is the same that was used in Bollgard Bt Cotton is also not justification to call it Cry1Ac or to make it more acceptable. There are many unresolved and uninvestigated issues with Bt Cotton too and this is all the more reason not to accept Bt Brinjal with the same gene. The Cry1Ac in Bt Brinjal is claimed to be “similar” in structure and activity to the one found in nature and in commercial microbial formulations and this is not true or scientific.

9. Page 11: 1.3.: Bt k formulations not having deleterious effects on non-target organisms including humans is not true. There have been records of negative effects with external sprays too. Further, even the external sprays are not recommended as safe, going by the instructions on such formulations in the market.

10. Page 12 (point on Bt Brinjal and IPM): “Contributes to and provides the foundation for an IPM strategy”, says the EC2 report. This is once again a faulty and unscientific understanding of Integrated Pest Management. See Annexure 6 for a note on how Bt crops are a violation of the principles of IPM and sustainable pest management approaches.

11. Page 12: Chronology of Bt Brinjal development: In 2002, the backcrossing began, after importing the plasmid from Monsanto in 2000. However, the pollen flow studies were also taken up in 2002 in two locations. How is this possible? Even with some techniques like Marker Assisted Backcrossing, at least three to five years and ideally five years, are required for true back-crossing. How can toxicity studies and allergenicity tests be undertaken without the backcrossing being completed properly in 2003 and 2004? It is only now that the scientists in Indian NARS are acknowledging how the backcrossing programme was not as good as it should have been in the case of Bt Cotton. What is the lesson learnt is not clear and obviously “experts” in the regulatory system are not paying attention to these issues.

12. Page 13 refers to Studies by the “technology provider” so, is the technology provider Monsanto in this case? If that is the case, the IPR implications have to be studied further. It should also be remembered that the studies being cited are on Cry1Ac (not the chimeric gene) and also do not constitute independent research. Nor are these peer-reviewed studies. The EC2 did not also mention which countries did not accept and allow certain products despite the regulatory authorities getting the studies cited here. The whole point is not to just accept the reports of the crop developer or technology provider but to take up independent research and analysis, which is sorely missing at this point of time.

13. Page 14: The public sector varieties have not been tried out in Large Scale Trials; they have finished the confined field trials in 2007 and 2008. This puts into question the event-based approval system adopted in India. It is obvious that no data exists on these Bt Brinjal varieties and their agronomic performance in a simple protocol that compares the Bt Brinjal variety with its isogenic counterpart and with the other best pest management options available, even though the Bt Brinjal varieties developed in the USAID-funded consortium project ABSPII are being recommended for release in India.

14. Section II: Review of regulatory compliance (pp 15-29) Around 15-16 pages of the Expert Committee report has focused on this whereas this does not make Bt Brinjal safe just by virtue of compliance to guidelines this cannot constitute safety evaluation and this is only a convenient deviation from the original terms of reference for a Bt Brinjal Sub Committee announced in January 2009. Further, even within this exercise, compliance with regulatory conditions stipulated by GEAC in the permit letter for LST is a wrong thing to do; the checking of compliance should have been against EC1’s recommendations.

15. Page 15, Table 2.1: The plasmid pMON10518 was imported by Mahyco in March 2000 It is not clear what the terms and conditions for this are, since this will determine the future of the public sector varieties being touted as the humanitarian side to this PPP effort. It will also determine the IPR issues around Mahyco’s Bt Brinjal hybrids, pricing issues etc.

16. PAGE 15: Table 2.1 list of regulatory approvals for tests: There are some questions with regard to permissions given and tests conducted here. For instance, the permission for sub-chronic feeding studies for 90 days in rabbits and goats was given on August 8th 2005 and preparation of feed concentrate for the feeding study happened on 22/12/2005 and 13/2/2006. It is not clear when sowing and harvesting would have taken place and whether fresh test material was supplied to the animals or not. The impact in the study could vary depending on the test material as well as time of harvest to time of diet preparation.

17. Page 16, Table 2.1: 2007 and 2008: Experimental seed production permissions were provided to the company thrice (Aug 2007, January 2008 and June 2008) Why was this done, even without the completion of large scale trials? How is this seed accounted for by the company? Has the GEAC verified the physical availability of these seeds and the biosafety compliance with respect to these stocks?

18. Page 16, Table 2.1: “19. Recommendation of RCGM with respect to 90 days goat feeding study with Bt brinjal leaf expressing cry1Ac gene. 12/ 81/ 2006-CS-II Feb 06, 2008” what is this referring to? If this was a permission from RCGM asking the company to take up the foliage feeding study also, then, the decision not to take up such studies came too soon after and the exact reason why this study was dropped is unclear. If this is a letter to Mahyco from RCGM that they need not take up the study as decided in earlier GEAC meetings and by the EC1, where the RCGM promptly communicated a decision from the January 2008 GEAC meeting, then the issue remains that the “conclusions” on Bt Cotton and animal morbidity/mortality by the GEAC are not scientific, based on any investigation nor is it a closed story (Annexure 9).

19. Page 17: Compliance with 1998 guidelines: Like Dr Bhargava had already pointed out elsewhere, the issue is not about compliance to existing guidelines this is a scientific evaluation which can and should question the earlier and existing guidelines too.

20. Page 17: Point 2.2 the fact that the RCGM did not do its job in its 40th meeting is already proven by the ECI comments and therefore, to repeat something that is known to be untrue will not make it true, in terms of compliance to 1998 guidelines.

21. Page 18 has an excerpt from the EC1 recommendation: “The EC-I further opined that the short term data generated on the environmental safety and socio economic aspects needs to be further substantiated with additional trials/tests to explicitly conclude the benefits from Bt brinjal and superiority of the technology with respect to existing technologies especially the available methods for pest management and pesticide reduction”. The EC1 came up with this in clear response to a point being raised by civil society groups and some scientists right from the beginning about the variety of alternative pest management practices available for farmers that are ecological, sustainable, affordable and farmer-controlled. This clearly requires Bt Brinjal to have been compared to other pest management methods and not necessarily chemical pesticide treated plots. This did not happen with Bt Brinjal assessment to this day. Table 2.2, points a. and b. conveniently ignore this fact and claim compliance!

22. Page 19: Table 2.2 a: Objective is to have an “independent assessment” by IIVR, an ICAR institution? How can this be possible, if IIVR is involved and why choose an ABSPII consortium partner if that is the objective?

23. At least three hybrids, MHB 11 Bt, MHB 39 Bt and MHB 99 Bt have not undergone second year MLRT trials (as apparent from Table 2.1 on Page 15; no trials took place in 2006-07, as is known to some activists who are following the various developments on the GM crops front in India and no permissions are visible in this table either or in the chronology explained on Pages 13-14 of EC2 report); However, Table 4.1. on Page 52 claims that these trials took place in 2006-07. It appears to be a case of the EC2 being more loyal than the King!

24. Page 20. Point c of table 2.2 on Pollen Flow: “Sufficient information is available on the biology of brinjal”, says the last column as EC2’s view. This information shows that brinjal is “an often cross-pollinated crop”, with outcrossing ranging between 2 to 48% in brinjal varieties in India. The EC2 then goes on to say in the last column against point c. of Table 2.2. that the “results are in conformity with earlier information supplied by the applicant and available literature”. These two don’t match and it is not clear how the EC2 reconciled this difference in favour of Mahyco (which claimed 1.46% to 2.7% in its pollen flow study, with IIVR reporting a 0.14% to 0.85% outcrossing in its pollen flow studies in the past two years)! This obviously shows a lot of variance to available literature.

25. Page 20: Point d of table 2.2: Crossability studies from melongena to incanum EC2 says that these “are in conformity with available literature”. However, this is in variance with some literature quoted by Dr Major Singh of IIVR in another paper put up on the GEAC website. Once again, the EC2 reconciled the difference in findings in favour of Mahyco in the current instance. Further, there are studies from TNAU which show crossability with other local species and this has not even been studied in the IIVR crossability studies nor does the EC2 make any reference to such knowledge existing within the NARS.

26. Data on Aggressive and weediness, on baseline susceptibility etc., was put up only recently and needs to be studied along with data from large scale trials etc.